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. 2026 Mar 2;21(3):e0341618. doi: 10.1371/journal.pone.0341618

Evaluation of peripheral intravenous line securement devices under clinically relevant loading and perspiratory conditions

George K H Morgan 1, Maegan Spiteri 1, Spyros Masouros 1,*
Editor: Federica Canzan2
PMCID: PMC12952575  PMID: 41770735

Abstract

Peripheral vascular access devices (PVADs) and their associated intravenous (IV) lines are widely used in clinical care. Securement devices are typically employed to prevent accidental dislodgement and complications such as occlusion and phlebitis. Despite the wide use of securement devices, there are no standardised methods for evaluating their actual ability to secure IV lines. This study assessed the securing ability of four commercially available IV line securement devices – Grip Lok, Javelo, micropore tape, and IV bracelet – under controlled laboratory conditions. First, all four devices were tested for resistance to axial pull-out forces using a uniaxial materials testing machine across ten participants. Participant comfort during testing was assessed via questionnaire. Grip-Lok and Javelo exhibited significantly greater axial pull-out strength than the other two devices (p-adj < 0.001), and were progressed to further testing, consisting of off-axis loading at 90°, 135°, and peel-off, and axial pull-out under simulated perspiration conditions. No significant differences were observed between Grip Lok and Javelo under loading in 90° and 135°. Javelo demonstrated superior performance in both peel-off and perspirant conditions (p-adj < 0.05). Javelo was rated the most comfortable by 60% of participants. The results highlight the need for incorporating realistic loading conditions and comfort metrics when evaluating the performance of infusion line securement aids. Furthermore, the results provide evidence that using a non-adhesive based device, particularly in patients with marked diaphoresis might provide more infusion line security, though further study is required.

1. Introduction

Peripheral vascular access devices (PVADs), such as peripheral intravenous catheters (PIVCs) and arterial lines, enable clinicians to deliver medical treatments and interventions rapidly. PVADs are the most frequently performed invasive medical procedure; an estimated 350 million PIVCs alone are purchased in the United States annually [1]. It is estimated that 60–90% of hospitalised patients require a PIVC during their care [2]. However, the effective securement of PVADs to patients remains a clinical challenge. PVAD failure rates of approximately 38–43% [3] are reported, with the most prominent failure types being occlusion or infiltration, dislodgement, and phlebitis [4–7]. These complications can delay treatment administration, increase infection risk and patient discomfort, and increase provider costs [8,9].

PVAD failure is influenced by the stability of connected intravenous (IV) treatment lines. Forces on these lines, for example due to an accidental pull or tangling, can destabilise the PVAD leading to complications or dislodgement [5–7,10–12]. Accordingly, securement devices can be used to anchor IV lines to the patient thus reducing the probability of PVAD failure and its consequences [7]. These securement devices are generally adhesive-based [3,13]. Various standards and guidelines recommend the use of such securement devices to prevent PVAD failure [13,14]. The need to enhance the performance of these securement devices has also been recognised [3,4], underscoring the importance of comparative testing methods to assess whether newer devices offer improvements over existing devices.

Despite the clinical importance of securement devices, standardised mechanical testing methodologies to evaluate their performance in securing IV lines remain underdeveloped. Studies investigating the mechanical performance of securement devices are limited, and often test only axial pull-out [15,16] or time-based catheter survival rates in clinical settings [17]. Additionally, clinically unwell patients are often perspirant, which healthcare staff have identified as a common factor leading to dislodgement [18]; yet, the effect of perspiration on maintaining adequate levels of securement has not been considered in tests. Furthermore, the success of a securement device in a clinical setting depends on patient acceptance and uptake, which is greatly impacted by the relative comfort of devices, yet patient comfort data for securement devices has not been reported.

This study first compared four commercially-available securement devices in terms of their mechanical resistance to axial pull-out forces, as previous studies have done. Two of the devices were subsequently tested for their mechanical resistance to forces applied at various angles, and for their resistance to axial pull-out forces in simulated perspiratory conditions. Participant comfort during axial pull-out testing was assessed using a questionnaire.

2. Methods

2.1 Experimental protocol

Ethical approval for this study was obtained from the Imperial College Science Engineering Technology Research Ethics Committee (number: 6590569). Ten healthy adult participants were recruited for the study between 6th November 2024 and 14th January 2025 and written informed consent was granted prior to testing. Exclusion criteria included: history of musculoskeletal injury in the hand or wrist area, known allergy to adhesives, and skin or connective tissue disorders.

2.1.1 Stage 1.

Four commercially available IV line securement devices were tested: micropore tape (3M, St. Paul, United States), Grip-Lok (TIDI Products, Neenah, United States), IV bracelet (Medow, Lund, Sweden), and Javelo Line Securement Gen 1 (Javelo Health, Edinburgh, United Kingdom). Each of the devices is shown applied according to manufacturer instructions in Fig 1.

Fig 1. Securement devices.

Fig 1

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The four IV line securement devices tested, shown applied to the arm according to manufacturer instructions and with IV line secured in the device in a linear line securement arrangement: (a) micropore tape, (b) Grip-Lok, (c) IV bracelet, (d) Javelo.

IV line segments (Intrafix Primeline; B. Braun, Melsungen, Germany) 85 mm in length and 4.1 mm in outer diameter were attached to a uniaxial materials testing machine (5866; Instron, Canton, USA), passed through a bespoke pulley fixture, and secured to participants’ right arms using IV line securement devices. The participants were then asked to rest their arms on an adjustable-height arm rest (Phlebotomy Arm Rest; Meditelle, Birmingham, United Kingdom). The arm rest was adjusted to align the IV line at 0°, such that the IV line lay straight through the device. For the Javelo device, this meant the arm was perpendicular to the IV line, as shown in Fig 1d. The test set-up is shown in Fig 2.

Fig 2. Pull-out testing setup.

Fig 2

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(a) Diagram of the test setup for a pull-out scenario in a uniaxial materials testing machine. Load cell, bespoke pulley fixture, device, IV line, and arm shown. (b) Photograph of the pull-out testing setup with micropore tape as the device used.

The IV line was pulled at a rate of 8 mm s-1 to a displacement of 150 mm, or until a maximum force of 20 N was reached. Force and displacement were recorded at the testing machine’s load cell. Each of the four devices was tested on the 10 participants, for a total of 40 tests. Device performance in Stage 1 was used to select devices to be tested in Stage 2 to reduce experiment time.

2.1.2 Stage 2.

Devices which performed favourably in Stage 1 trials were subsequently taken forward in Stage 2, whereby the devices were tested on the right arm of each participant with the IV line at an angle to the device, and in pull-out under induced perspiration.

Testing at an angle: A similar testing setup as shown in Fig 2 in Stage 1 trials was used, but the arm rest was positioned such that the IV line passed through the devices at an angle of 90° or 135°, as shown in Fig 3a and 3b, respectively, or the arm rest was aligned in the pull-out position, but with the pulley fixture removed, simulating a ‘peel-off’ scenario, as shown in Fig 3c. These loading conditions were selected to capture a range of possible realistic scenarios during clinical use.

Fig 3. Diagrams of the different testing setups.

Fig 3

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(a) Bird’s eye view of the pull-out test, (b) bird’s eye view of the 135° test, (c) bird’s eye view of the 90° test, (d) peel-off testing setup, which is identical to the pull-out test but with the pulley fixture removed.

Perspiration: One of each device was applied to each arm of each participant, with the devices randomly assigned to the arms, and the participants were asked to perform cardiovascular exercises of their choice to induce perspiration. Perspiration was detected using water contact indicator tape (3M, St. Paul, United States) which was applied to the arms of each participant next to the devices. Once perspiration was detected as shown in Fig 4, the participants were asked to continue to exercise for five additional minutes, and then the pull-out test from Stage 1 was performed. For all Stage 2 tests, IV lines were pulled at a rate of 8 mm s-1 to a displacement of 150 mm, or until a maximum force of 20 N was reached. Each of the devices was tested on 10 participants.

Fig 4. Perspiration indicator.

Fig 4

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Water contact indicator tape applied to participant’s arm next to device. Indication of perspiration was identified by a solid red line around the full-perimeter of the tape segment, with red penetrating towards the centre of the tape segment: (a) before cardiovascular exercise, (b) part-way through exercise with partial indication, (c) full indication at which point participants performed five additional minutes of exercise before testing commenced.

2.2 Comfort survey

Participants were asked the following to assess their comfort during the Stage 1 trials, and their responses were recorded: “Please provide a ranking for each of the tested devices based on your perception of their comfort during the testing, with 1 being the most comfortable and 4 being the least comfortable”.

2.3 Data analysis

2.3.1 Stage 1.

A Friedman test was performed on the mean peak force recorded for each of the four devices. Post-hoc Wilcoxon signed-rank tests with a Benjamini-Hochberg multiple-comparisons correction procedure were performed to compare the mean peak forces for each pair of devices. A significance threshold of α < 0.05 was used.

2.3.2 Stage 2.

One-tailed Wilcoxon signed-rank tests with a Benjamini-Hochberg multiple-comparisons correction procedure were performed to compare the mean peak force recorded for the devices included in Stage 2 trials for each of the four tests performed: 90°, 135°, peel-off, and perspirant pull-out. A significance threshold of α < 0.05 was used.

3. Results

The peak forces for each device during the Stage 1 trials and the results of a Friedman test with post-hoc Wilcoxon signed-rank tests between each device pair are shown in Fig 5. There were significant (p-adj < 0.001; p-value adjusted using Benjamini-Hochberg correction procedure for multiple comparisons) differences in the mean peak forces for every device pair except between the Grip-Lok and Javelo, which had no significant difference in mean peak forces (p-adj > 0.05; p-value adjusted using Benjamini-Hochberg correction procedure for multiple comparisons). The Grip-Lok and Javelo had the highest mean peak forces in Stage 1 trials, so these devices were progressed to Stage 2 trials.

Fig 5. Stage 1 results.

Fig 5

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Box and whisker plots of peak forces during pull-out (Stage 1) testing for each of the four devices tested: micropore tape, Grip-Lok, Javelo, and Medow. The results of a Friedman test with post-hoc Wilcoxon signed-rank tests with a Benjamini-Hochberg correction procedure are displayed. n = 10. ***p-adj < 0.001; ns = no significance.

The peak forces for the Grip-Lok and Javelo in the four testing methods in Stage 2 trials, along with the results of a one-tailed Wilcoxon signed-rank test between the Grip-Lok and Javelo devices for each of the four testing methods are shown in Fig 6. The mean peak force of the Javelo was significantly greater (p-adj < 0.05; p-value adjusted using Benjamini-Hochberg correction procedure for multiple comparisons) than that of the Grip-Lok for the peel-off and perspirant pull-out tests. There was no significant difference between the devices in the 90° and 135° angled pull-out tests.

Fig 6. Stage 2 results.

Fig 6

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Paired plots of peak forces during the angled and perspiration pull-out (Stage 2) testing: 90°, 135°, peel-off, and perspiration pull-out. The Grip-Lok and Javelo devices were tested. The results of one-tailed Wilcoxon signed-rank tests with a Benjamini-Hochberg correction procedure between the devices for each of the four tests are displayed. n = 10. *p-adj < 0.05; ns = no significance.

The results of the comfort survey, which was completed by participants immediately after Stage 1 trials, are shown in Table 1. The average rank of each device across the 10 participants, as well as the proportion of participants that ranked each device as the most comfortable, are shown.

Table 1. Comfort survey results. The results of the comfort survey completed by participants after Stage 1 trials. The average rank for each device (where 1 is most comfortable and 4 is least comfortable) and the proportion of participants that ranked each device as ‘most comfortable’ are shown. n = 10.

Device Micropore tape Grip-Lok Medow Javelo
Average rank 3.3 2.8 2.2 1.7
Ranked most comfortable 0% 20% 20% 60%
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The data resulting from the Stage 1 trials, Stage 2 trials, and comfort survey are publicly available in a Zenodo depository [19].

4. Discussion

The results of this study demonstrate that the Grip-Lok and the Javelo were the superior options for IV line securement in axial pull-out testing, with both devices exhibiting significantly greater resistance to dislodgement compared to their adhesive-based counterparts, micropore tape and the Medow IV bracelet. This finding aligns with previous studies highlighting the importance of securement devices in reducing PVAD failure rates and underscores the necessity of robust mechanical performance in clinical practice [3,4].

When evaluating securement performance under angled loading conditions, no significant difference was observed between the Grip-Lok and the Javelo in the 90° or 135° orientations. This suggests that both devices provide comparable resistance to dislodgement when subjected to off-axis forces, which is a relevant consideration in clinical settings where IV lines are frequently exposed to multidirectional forces due to patient movement. While axial pull-out testing is the accepted method for securement devices, this test does not fully encapsulate the range of mechanical environments experienced in clinical settings. Axial pull-out may be used as a test to exclude underperforming devices, but resistance to axial forces alone is not sufficient to determine overall device efficacy. While all devices investigated in this study were tested with a linear line securement arrangement, as shown in Fig 1, future studies should investigate the performance of devices with ‘looped’ IV lines, as is sometimes recommended for clinical use and may affect pull-out resistance performance.

The Javelo device demonstrated superior performance to the Grip-Lok in both peel-off and perspirant conditions, with significantly greater peak force required for detachment. Given the widespread use of adhesive-based securement devices, these findings emphasize the critical influence of skin moisture on device performance. The reduction in securement strength observed with the Grip-Lok under perspiration highlights the potential for device failure in febrile or diaphoretic patients, where adhesive degradation may compromise line stability. These findings suggest that non-adhesive devices should be recommended instead of adhesive-based devices for use on potentially febrile or diaphoretic patients, such as those with infection, acute medical illness, or traumatic injury, though further investigation is needed. Additionally, as perspirant conditions can significantly affect device performance, and are likely to be encountered clinically, mechanical testing aimed to qualify securement devices should include testing under perspirant conditions.

An additional, qualitative observation from this study was that the Grip-Lok exhibited reduced effectiveness in participants with substantial arm hair, whereas the Javelo appeared unaffected. Although arm-hair density was not recorded, the qualitative observation suggests that hair density may be a confounding factor in securement performance, particularly for adhesive-based devices. Future studies should consider including hair-density measurements to assess its impact on mechanical securement, thereby informing design adaptations for more effective universal application across diverse patient populations. Furthermore, differences in device performance when applied to the left or right arm, or to the dominant or non-dominant arm, were not measured in this study. Arm dominance may affect the performance of these devices due to differences in size, perspiration, and hair density. Future studies should investigate the effect of arm dominance on device performance, as devices are most commonly applied to the non-dominant arm in clinical settings.

Beyond mechanical performance, comfort is a critical determinant of patient adherence and device acceptability. The subjective rankings collected in this study indicated that the Javelo was the most preferred device, with 60% of participants ranking it as the most comfortable option. The Javelo and the Medow IV bracelet were rated as more comfortable than the micropore tape and the Grip-Lok, suggesting that adhesive devices are less comfortable than non-adhesive devices. Future device development and testing should consider and report patient comfort as a key metric, as improved comfortability will increase clinical compliance and long-term catheter retention.

This study addresses the mechanical performance and testing of securement devices, but other mechanisms of PVAD failure, such as phlebitis and occlusion, remain unaddressed. A large-scale clinical trial comparing all-cause PVAD failure rates when using different securement devices should be performed. Data from sub-populations, such as those likely to perspire during treatment, can additionally address specific securement device recommendations for these sub-populations. This study is a step towards addressing the overall problem of PVAD failure and can be used to inform device selection in a future clinical trial, as well as to inform methodologies of future mechanical studies investigating PVAD dislodgement, and regulatory mechanical testing protocols.

5. Conclusions

This study is the first to compare IV line stabilisation devices under a range of loading conditions expected in clinical scenarios, including angled force application and testing under perspirant conditions. The devices tested experienced a large range of axial pull-out force. Two of the four devices, one adhesive-based and one non-adhesive based, were able to withstand expected forces without dislodgement under all loading conditions, but the adhesive-based one was not able to withstand forces under perspiration conditions. These findings should be investigated further with a larger sample size, and further parameters should be investigated, such as the effect of the line securement arrangement used and the influence of hand-dominance on device stability. The findings of this study highlight the importance of testing securement devices beyond standard axial pull-out methodologies. As perspiration was found to impact significantly adhesive-based securement, future mechanical assessments should consider incorporating moisture conditions to ensure robust device performance in diverse patient populations and clinical settings.

Acknowledgments

The mechanical testing was conducted in the EPSRC Injury and Reconstruction Biomechanics Test Suite. For the purpose of open access, the authors have applied a Creative Commons Attribution (CC BY) license to any Author Accepted Manuscript version arising.

Data Availability

All force and displacement data from the Stage 1 and Stage 2 testing, as well as the results of the comfort survey, are available at Zenodo: https://doi.org/10.5281/zenodo.16317677.

Funding Statement

The consumables, arm rest, and devices used in this study were provided courtesy of Javelo Health. GM was supported by a DTP studentship from the Engineering and Physical Sciences Research Council (EP/T51780X/1). The mechanical testing was conducted in the EPSRC Injury and Reconstruction Biomechanics Test Suite (EP/S021752/1).

References

  • 1.Thompson J, Steinheiser MM, Hotchkiss JB, Davis J, DeVries M, Frate K, et al. Standards of care for peripheral intravenous catheters: evidence-based expert consensus. J Assoc Vasc Access. 2024;29(3):15–26. doi: 10.2309/java-d-24-00011 [DOI] [PubMed] [Google Scholar]
  • 2.Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015;38(3):189–203. doi: 10.1097/NAN.0000000000000100 [DOI] [PubMed] [Google Scholar]
  • 3.Rickard CM, Marsh N, Webster J, Runnegar N, Larsen E, McGrail MR, et al. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial. Lancet. 2018;392(10145):419–30. doi: 10.1016/S0140-6736(18)31380-1 [DOI] [PubMed] [Google Scholar]
  • 4.Larsen EN, Marsh N, O’Brien C, Monteagle E, Friese C, Rickard CM. Inherent and modifiable risk factors for peripheral venous catheter failure during cancer treatment: a prospective cohort study. Support Care Cancer. 2021;29(3):1487–96. doi: 10.1007/s00520-020-05643-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Marsh N, Webster J, Larson E, Cooke M, Mihala G, Rickard CM. Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: a multivariable analysis of peripheral intravenous catheter failure. J Hosp Med. 2018;13(2):83–9. doi: 10.12788/jhm.2867 [DOI] [PubMed] [Google Scholar]
  • 6.Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, et al. Peripheral intravenous catheter failure: a secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021;124:104095. doi: 10.1016/j.ijnurstu.2021.104095 [DOI] [PubMed] [Google Scholar]
  • 7.Bolton D. Improving peripheral cannulation practice at an NHS Trust. Br J Nurs. 2010;19(21):1346–50. doi: 10.12968/bjon.2010.19.21.79998 [DOI] [PubMed] [Google Scholar]
  • 8.Bausone-Gazda D, Lefaiver CA, Walters S-A. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. J Infus Nurs. 2010;33(6):371–84. doi: 10.1097/NAN.0b013e3181f85be2 [DOI] [PubMed] [Google Scholar]
  • 9.Cooke M, Ullman AJ, Ray-Barruel G, Wallis M, Corley A, Rickard CM. Not “just” an intravenous line: Consumer perspectives on peripheral intravenous cannulation (PIVC). An international cross-sectional survey of 25 countries. PLoS One. 2018;13(2):e0193436. doi: 10.1371/journal.pone.0193436 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 10.Indarwati F, Mathew S, Munday J, Keogh S. Incidence of peripheral intravenous catheter failure and complications in paediatric patients: systematic review and meta analysis. Int J Nurs Stud. 2020;102:103488. doi: 10.1016/j.ijnurstu.2019.103488 [DOI] [PubMed] [Google Scholar]
  • 11.Bahl A, Clement V, DiLoreto E, Mielke N, Carr A, Panza G, et al. Evaluating the impact of external forces on peripheral intravenous catheter movement using ultrasound: a randomized pilot study. J Vasc Access. 2025;26(1):102–8. doi: 10.1177/11297298231222052 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Munoz-Mozas G. Solving the problem of IV dislodgement. Br J Nurs. 2022;31(2):S4–7. doi: 10.12968/bjon.2022.31.2.S4 [DOI] [PubMed] [Google Scholar]
  • 13.Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, et al. Infusion therapy standards of practice, 9th edition. J Infus Nurs. 2024;47(1S Suppl 1):S1–285. doi: 10.1097/NAN.0000000000000532 [DOI] [PubMed] [Google Scholar]
  • 14.O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011;52(9):e162-93. doi: 10.1093/cid/cir257 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Rutledge LF, DeCabooter DP, Walters S-AH, Bernatchez SF. Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a securement dressing, and sutures in a pig model. Intensive Care Med Exp. 2015;3(1):60. doi: 10.1186/s40635-015-0060-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Schmutz A, Menz L, Schumann S, Heinrich S. Dislodgement forces and cost effectiveness of dressings and securement for peripheral intravenous catheters: a randomized controlled trial. J Clin Med. 2020;9(10):3192. doi: 10.3390/jcm9103192 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 17.Smith B. Peripheral intravenous catheter dwell times: a comparison of 3 securement methods for implementation of a 96-hour scheduled change protocol. J Infus Nurs. 2006;29(1):14–7. doi: 10.1097/00129804-200601000-00004 [DOI] [PubMed] [Google Scholar]
  • 18.Moureau N. Impact and safety associated with accidental dislodgement of vascular access devices: a survey of professions, settings, and devices. J Assoc Vasc Access. 2018;23(4):203–15. doi: 10.1016/j.java.2018.07.002 [DOI] [Google Scholar]
  • 19.Morgan G, Spiteri M, Masouros S. Evaluation of peripheral vascular access line securement devices under clinically relevant loading and perspiratory conditions. Zenodo; 2025. doi: 10.5281/ZENODO.16317678 [DOI] [PMC free article] [PubMed] [Google Scholar]

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16 Nov 2025

Dear Dr. Masouros,

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The consumables, arm rest, and devices used in this study were provided courtesy of Javelo Health. GM was supported by a DTP studentship from the Engineering and Physical Sciences Research Council (EP/T51780X/1). The mechanical testing was conducted in the EPSRC Injury and Reconstruction Biomechanics Test Suite (EP/S021752/1). For the purpose of open access, the authors have applied a Creative Commons Attribution (CC BY) license to any Author Accepted Manuscript version arising.

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The consumables, arm rest, and devices used in this study were provided courtesy of Javelo Health. GM was supported by a DTP studentship from the Engineering and Physical Sciences Research Council (EP/T51780X/1). The mechanical testing was conducted in the EPSRC Injury and Reconstruction Biomechanics Test Suite (EP/S021752/1).

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Partly

Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: I Don't Know

Reviewer #2: No

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3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: No

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4. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: General comment:

Effective stabilisation and securement of intravenous peripheral vascular access devices (PVAD - the cannula, insertion needle, integrated components – wings, needle-free connectors etc.) can help to reduce therapy failure and have become important topics of research and feature in preventative care bundles.

Infusion lines when connected to PVADs and infusion line ‘addons’ (in-line filters, stopcocks etc.) are implicated in complications like mechanical phlebitis and accidental dislodgment, particularly amongst mobile, physically active or confused patients. However, unless they are part of a closed infusion system, they are not generally considered as the PVAD itself.

Confusingly the article refers to PVAD stabilisation/securement and the securement of the associated infusion lines as the same. Whilst intimately related the two are not the same and should be differentiated. Whilst I accept that this situation might reflect the relative sparsity of research literature on the securement of infusion lines (as acknowledged in the article - many of the supporting citations refer to PVAD stabilisation or securement) it should be clarified by the authors that the study is about infusion line securement and not PVAD securement.

Specific comments:

Title:

Rather than referring to’ access line’ in the title it might be better phrased as ‘infusion line’ to clarify you are not referring to needle-free connectors or other.

Abstract:

Lines 35-37 I am not sure if the conclusions can be stated as unqualified as the text suggests. It might be better phrased more tentatively as this example: ‘The results highlight the need for incorporating realistic loading conditions and comfort metrics when evaluating the performance of infusion line securement aids. Furthermore, the results provide evidence that using a non-adhesive based device, particularly in patients with marked diaphoresis might provide more infusion line security, though further study is required.

Introduction:

Line 52-54, needs supporting citations (lots available) which will support the importance of your research.

Lines 56- 57, citation number 7 is incorrect in the reference list. Angie Malone was one of the reviewers for the Infusion Nurses Society standards publication. The correct citation is probably: Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, et al., Infusion therapy standards of practice. 9th ed. J Inf Nurs, 2024. 47(1S): p. S1-285. doi:10.1097/NAN.0000000000000532. Please check and clarify.

citation number 8 is concerned with central vascular access and not peripheral vascular access – does it also consider the securement of infusion lines? Clarify.

Methods:

Line 80, presumably healthy adult patients (they were asked to undergo physical activity to create sweating – clarify.

Line 84 stage 1 and line 109, of the four devices applied to all 10 participants were they distributed between both left and right arms or was one used in preference? Clarification might support decision in line 127.

Lines 85-87, it might be required to recognise trademarks™® and copyright© in the text, check journal author guidelines. 3M products are now marketed under the company name Solventum in the UK.

Line 88, Figure 1 suggests that all the devices were testing with a linear line securement arrangement – this is fine for the experimental set up, but some important confounding variables are introduced with this approach. For example, many using adhesive based aids in practice loop the lines to ensure better and more comfortable line security. In addition, the IV bracelet instructions for clinical use suggest looping the line back though the holder. This might impact on pull resistance. Please expand on this in a consideration of study limitations in your discussion.

Line 94, State the outer diameter of the experimental infusion line to confirm that it is compatible with the design parameters of the tested devices.

Line 113, why was this done? Time practicalities of the experimental set up, availability of participants or do you have any evidence (or theory) that devices that perform less will under uniaxial forces also perform less well under angular (135, 90 degree forces)? Comment.

Line 127, did stage 1 results support a view that there were no differences between either arm (hairiness reported to affect tape adhesion -line 226 – arms might not be equally hirsute). Comment.

Results:

Line 189, more information about the ‘questionnaire’/ ‘comfort survey’ would be welcome. For example, how sophisticated was this tool? How were participants asked about comfort to enable them to rank it? Comfort during application, wearing, removal, visual appearance etc.

Discussion:

Please add a more detailed consideration of ‘Study limitations and recommendations for future work’ to the discussion.

Conclusion:

Please see comments re abstract.

References:

Require revision to presented in the journal style.

Infusion line securement when done effectively can ensure infusion system integrity, prevent entanglements and reduce PVAD and infusion related complications. It is an understudied and underappreciated aspect of safe infusion therapy and articles like this are to be welcomed.

Whilst many clinical settings will have preferred products and arrangements for peripheral infusion scenarios studies like this one can add to the development of meaningful evidence to enable clinicians to compare experimental outcomes with (future) real world performance of their approaches.

Reviewer #2: The research titled “Evaluation of Peripheral Vascular Access Line Securement Devices Under Clinically Relevant Loading and Perspiratory Conditions” addresses a highly relevant and important topic that warrants further investigation.

However, the study seems small-scale experiments rather than a comprehensive research effort. In the introduction, the authors note that “the effective securement of PVADs to patients remains a clinical challenge,” citing PVAD failure rates of approximately 38–43%, primarily due to occlusion, infiltration, dislodgement, and phlebitis. Despite this, the study focuses primarily on resistance to load and patient comfort, which only partially reflect the broader clinical challenges identified. Consequently, the problem statement, research objectives, and results appear misaligned.

Furthermore, the sample size, including both the number of participants and the types of tests performed, seems insufficient to draw meaningful conclusions about the overall effectiveness of PVAD securement devices.

In the results section, the authors report that “the mean peak force of the Javelo was significantly greater (p-adj < 0.05; p-value adjusted using the Benjamini–Hochberg correction procedure for multiple comparisons) than that of the Grip-Lok for the peel-off and perspirant pull-out tests. There was no significant difference between the devices in the 90° and 135° angled pull-out tests.” However, these reported significant differences were not clearly reflected in Figure 6

Overall, while the research topic is both interesting and potentially impactful, the study’s methodology, experimental design, and data interpretation appear weak and require substantial improvement to support the stated conclusions.

**********

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Reviewer #1: No

Reviewer #2: No

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PLoS One. 2026 Mar 2;21(3):e0341618. doi: 10.1371/journal.pone.0341618.r002

Author response to Decision Letter 1

12 Dec 2025

Response to editor comments:

We thank the editor for their comments. Please find below a response to each of the points raised.

1. The manuscript has now been edited to match PLOS One’s style requirements, including those of file naming.

2. The data repository is already uploaded and is available to reviewers and editors at the Data Review URL provided in the file system. Reference to this repository has been added to the manuscript text and references. The repository is currently restricted such that only those with this Data Review URL (editors and reviewers) are able to access it. On acceptance of the manuscript, the repository will be changed from 'restricted' to 'open' access. This change will take effect instantly.

3. All funding has been removed from the acknowledgements section of the manuscript. The current funding statement is correct.

4. Author ‘Spyros Masouros’ is listed on the manuscript as author ‘Spyros D. Masouros’.

5. Author ‘Spyros Masouros’ has been amended to ‘Spyros D. Masouros’ in the manuscript submission data.

6. Affiliation information has now been added for all authors in the manuscript.

7. No copyright images are contained in any of the figures in this submission. Figures 1 and 4 consist of photos taken by and of the authors during preliminary testing. Figures 2 and 3 were also created by the authors using photos taken by and of the authors during preliminary testing, and diagrams (all part of the diagram, including the hand, rest, and testing machine) which were drawn by the authors.

8. This has been noted. No specific works were recommended by the reviewers. Several references have been added to the manuscript.

Response to reviewer 1:

We thank the reviewer for their comments. We hope that the changes in the manuscript and the responses below sufficiently address the reviewer’s concerns.

Title:

The title has been changed to ‘infusion line’ rather than ‘access line’.

Abstract:

Lines 35-37: the text has been changed as recommended.

Introduction:

The distinction between PVAD and IV line and securement has now been clarified throughout the manuscript, and it has been made more clear that this study investigates IV line securement.

Lines 52-57: Additional citations have been added, and citation number 8 has been removed as it does not consider the securement of peripheral vascular access.

Methods:

Line 80: The text has been amended to specify that the participants were healthy adults.

Lines 85-87: The PLOS One author guidance states that PLOS One “cannot publish copyright symbols such as ©, ®, or ™.” The water contact indicator tape used was purchased from ‘3M’ and no equivalent product is available under Solventum, so we have left the manufacturer name as ‘3M’ to aid in reproducibility.

Line 88: The following text has been added to the discussion section to state the limitation of this study to linear line securement arrangements, and to suggest that future studies investigate alternative arrangements:

“While all devices investigated in this study were tested with a linear line securement arrangement, as shown in Figure 1, future studies should investigate the performance of devices with ‘looped’ IV lines, as is sometimes recommended for clinical use and may affect pull-out resistance performance.”

Lines 109, 120, 133: The text now specifies that only participant’s right arms were used in phase 1 and in the angled testing of phase 2, and that the devices were randomly assigned to each arm in the perspirant testing in phase 2. The right arm was used during angled testing for laboratory space constraints, but this constraint was not present for pull-out testing, so the devices were randomly assigned to arms for perspirant pull-out so that only one round of perspiration was required per participant. The following text has also been added to the ‘study limitations’ section of the discussion:

“Furthermore, differences in device performance when applied to the left or right arm, or to the dominant or non-dominant arm, were not measured in this study. Arm dominance may affect the performance of these devices due to differences in size, perspiration, and hair density. Future studies should investigate the effect of arm dominance on device performance, as devices are most commonly applied to the non-dominant arm in clinical settings.”

Line 101: The outer diameter of the infusion line has now been specified in the text.

Line 113: The following text was added to clarify why phase 1 testing results were used to reduce testing time and the time-commitment of participants, as was recommended by the internal ethical review panel:

“Device performance in Stage 1 was used to select devices to be tested in Stage 2 to reduce experiment time.”

Results:

The exact wording of the comfort survey has been added to the methodology section and is copied below:

“Please provide a ranking for each of the tested devices based on your perception of their comfort during the testing, with 1 being the most comfortable and 4 being the least comfortable.”

Discussion:

Additional considerations of study limitations and future studies have been added to the discussion section.

Conclusion:

The following text has been added to the conclusion section:

“These findings should be investigated further with a larger sample size, and further parameters should be investigated, such as the effect of the line securement arrangement used and the influence of hand-dominance on device stability.”

References:

The referencing has been changed to the journal’s style.

Response to reviewer 2:

We thank the reviewer for their comments. We hope that the changes in the manuscript and the responses below sufficiently address the reviewer’s concerns.

With regards to the alignment of the problem statement and study objectives, the introduction section has been modified to clarify that the objective is the securement of IV lines, in order to reduce PVAD failure rates.

With regards to the small sample size used, the following text has been added to the conclusion section, in addition to further discussion on general study limitations throughout the discussion section:

“These findings should be investigated further with a larger sample size, and further parameters should be investigated, such as the effect of the line securement arrangement used and the influence of hand-dominance on device stability.”

With regards to the statistical significance of the comparisons presented in Figure 6, the Figure has been modified to improve the clarity of the statistical significances. Statistically significant paired comparisons are denoted with a ‘*’, and non-significant paired comparisons are denoted with ‘ns’, as described in the figure caption.

With regards to the study’s methodology and data interpretation, please see the revised manuscript where further details and clarifications have been added where necessary. The study’s methodology has been reported fully and accurately, and all data collected in this study are made available at Zenodo for reviewers and editors, and will be made openly accessible upon manuscript acceptance.

We agree with the reviewer that the problem of PVAD failure described in the introduction is a greater problem than has been addressed in our study. Our study is a step towards addressing this problem, beginning with the mechanical aspect of line securement and the best methodologies for comparing mechanical performance. We indeed believe that a larger scale trial comparing these devices in a clinical setting would be best-equipped to address the overall problem, and we believe that our study can be a step towards this direction in that it can narrow-down possible devices, as well as inform future regulatory pre-clinical testing. The following text has been added to the discussion to highlight these points:

“This study addresses the mechanical performance and testing of securement devices, but other mechanisms of PVAD failure, such as phlebitis and occlusion, remain unaddressed. A large-scale clinical trial comparing all-cause PVAD failure rates when using different securement devices should be performed. Data from sub-populations, such as those likely to perspire during treatment, can additionally address specific securement device recommendations for these sub-populations. This study is a step towards addressing the overall problem of PVAD failure and can be used to inform device selection in a future clinical trial, as well as to inform methodologies of future mechanical studies investigating PVAD dislodgement, and regulatory mechanical testing protocols.”.

Attachment

Submitted filename: IV_Securement_Response_to_reviewers.docx

pone.0341618.s002.docx (27.8KB, docx)

Decision Letter 1

Federica Canzan

11 Jan 2026

Evaluation of peripheral intravenous line securement devices under clinically relevant loading and perspiratory conditions

PONE-D-25-39960R1

Dear Dr. Masouros,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Federica Canzan

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions??>

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

**********

Reviewer #1: General comment:

Thank you for submitting your revised manuscript and responding to my previous reviewer comments. There are a few minor specific items, shown below that require consideration before publication.

Specific comments:

I note your response to my previous review suggestion stating that you have changed the title to use ‘infusion line’. However, this is not evident in the revised clean and track changes copy of the manuscript. The word ‘infusion’ is missing, consider revising the title to use the phrase ‘intravenous infusion line securement’ as to my mind this adds further clarity for readers.

Line 60 track changes (line 54 clean copy), I wonder if a minor revision to the sentence beginning: ‘Accordingly ….’ might better set the scene for readers and delineate your use of the word ‘securement’ to refer to infusion line securement in the rest of the manuscript. Perhaps: ‘Accordingly adjunct IV infusion line securement devices and techniques are widely used to anchor IV lines to the patient to reduce the risk of PVAD failure’.

Line 272 track changes (line 260 clean copy), perhaps additional sub-populations that present additional challenges for real world care complexities when securing IV infusion lines could be identified here – think about ambulant patients, confused/noncompliant patients, and children.

**********

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If you choose “no”, your identity will remain anonymous but your review may still be made public.

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Reviewer #1: No

**********

Acceptance letter

Federica Canzan

PONE-D-25-39960R1

PLOS One

Dear Dr. Masouros,

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Academic Editor

PLOS One

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    Attachment

    Submitted filename: IV_Securement_Response_to_reviewers.docx

    pone.0341618.s002.docx (27.8KB, docx)

    Data Availability Statement

    All force and displacement data from the Stage 1 and Stage 2 testing, as well as the results of the comfort survey, are available at Zenodo: https://doi.org/10.5281/zenodo.16317677.

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