Abstract
Aim
To determine peripheral intravenous catheter (PIVC) characteristics, complications and risk factors among patients in cancer units.
Methods
A secondary analysis of a global, cross-sectional study (127 hospitals in 24 countries). Participants (≥18 years) admitted to cancer units were assessed once for PIVC characteristics and the presence of complications. Variables included patient demographics, device characteristics, treatment details, and device and/or site complications. PIVC characteristics were presented using qualitative descriptors; mixed-effects logistic regression models determined risk factors for PIVC complications.
Results:
In total, 1,807 participants (1,812 PIVCs) were included; 12% (n=215) of PIVCs presented with complications. Risk factors included: insertion by doctors; insertion in ED and ambulance/other locations; poor PIVC dressing integrity; dwell time ≥49 hours; and administration of colloids/blood products and antiemetics.
Conclusions
At least one in ten PIVCs in cancer units present with complications; regular PIVC assessment and improved dressing integrity is likely to reduce risk and improve outcomes.
Keywords: oncology, haematology, peripheral venous catheter
Introduction
The prevalence of cancer is a growing burden upon healthcare systems, with approximately 14 million new cases identified each year worldwide1. Cancer survivors are also an expanding population; in the United States alone, this number is soon expected to reach 18 million2, with 61% aged ≥65 years3. For many patients with cancer, vascular access devices are an essential lifeline during treatment and beyond.
Peripheral intravenous catheters (PIVCs) are regularly used to administer intravenous (IV) infusates, including blood, chemotherapy, fluids and supportive care drugs, in the treatment of cancer4. These devices are indicated for shortterm, peripherally-compatible IV treatments5 but have garnered concern, particularly in relation to extravasation risk following infusion of anti-neoplastic agents6. A recent study found 35% of PIVCs within an oncology/haematology population failed, due to mechanical (i.e. infiltration / occlusion) and/or infective and inflammatory (i.e. local or bloodstream infection (BSI) / phlebitis) complications4. Despite being common, PIVC failure may have dire consequences. The chronic nature of cancer and the frequency of treatment required often results in venous depletion due to recurrent cannulation attempts7. Moreover, these patients often present with risk factors such as immunosuppression, malnutrition and complex treatment needs, potentially increasing the likelihood of severe complications such as BSI8,9.
While central venous access device (CVAD) use is common among oncology and haematology patients for long-term IV treatments and high-risk or peripherally-incompatible infusates (e.g. parenteral nutrition),6 PIVC use is often a practical and unavoidable solution for emergent treatments and when drug incompatibilities exist10. However, there is a paucity of research investigating PIVC characteristics among this cohort. To address this evidence gap, we conducted a secondary analysis of data collected from a large multi-national, cross-sectional PIVC study11. Our goal was to identify characteristics of PIVCs and both modifiable and non-modifiable risk factors of PIVC complications, specific to inpatients in acute hospital cancer units.
Methods
Objectives
To determine the characteristics of PIVCs in patients admitted to cancer units internationally.
To establish risk factors (both modifiable and inherent) for presence of PIVC complications.
Sample population
The One Million Global Catheters (OMG) study was an international cross-sectional study of PIVC characteristics and use conducted between 1 June 2014 and 31 July 201511. This large project collected data from 40,620 PIVCs (38,161 patients) in 51 countries11. All patients (and PIVCs) admitted to cancer units (oncology and haematology), regardless of underlying diagnosis, were eligible for this sub-analysis. Individual patient level data was not collected; therefore, aspects such as admitting diagnosis or underlying oncological or haematological condition could not be ascertained.
Ethical considerations
Human Research Ethics Committee approval for the sub-analysis was provided by Griffith University (2019/437). As de-identified data was sourced from an existing (ethically approved) dataset, patient consent was not required.
Variables
The OMG study used a point-prevalence design where participant and device characteristics, and signs and symptoms of PIVC site complications were observed for each patient at each site at a single point in time. Variables included:
Participant characteristics: age (in years); gender; treatment (e.g. fluids, medications) administered on the assessment day.
Insertion setting: location of patient (e.g. ward, emergency); time of day (e.g. Monday–/Friday; weekend; day; evening).
Device characteristics: inserting clinician; reason for insertion; gauge/size; insertion site (e.g. forearm, hand); PIVC dwell time (in hours) at time of assessment.
Device and site assessment: signs and symptoms of complications related to phlebitis and infection; malfunction; and skin reaction.
Patient satisfaction: patient’s experience with PIVC, scored on an 11-point numerical rating scale (0, worst; 10, best).
The data collection form/s are publicly available11.
Outcomes
The primary outcome of interest was a composite measure of the presence of PIVC complications including any of:
Signs and symptoms of phlebitis and infection: this included pain/tenderness, redness/erythema, swelling, palpable cord, vein streak, extravasation/infiltration, induration/hardness, and/or purulence, AND/OR
Signs of malfunction: including leakage or partial/complete dislodgement.
For the purposes of the analysis, other reported complications such as blood in line, bruising/dried blood, and skin reactions (itch/rash, blistering/skin tears) were presented descriptively but not included in the multivariable analyses as complications.
Analysis
PIVC insertion and treatment characteristics and presence of complications were reported descriptively (using absolute numbers and proportions). Missing data were not imputed as they were not assumed to be missing at random given the data collection method. Mixed-effects logistic regression models were used to assess predictors of complications, accounting for the clustering of the data within hospitals and regions. Odds Ratio (OR) with 95% Confidence Intervals (CI) were reported. Variables significant at p<0.2 in the univariable modelling were included in the multivariable model. Clinically relevant variables selected a priori were included in multivariable modelling irrespective of statistical significance at univariable analysis, including patient age, PIVC location (anatomical position), and PIVC gauge/size12,13. Data were analysed using Stata (V13; StataCorp, College Station, TX).
Results
Oncology and haematology participants made up 4.7% (n=1,807/38,161) of the total OMG study population, representing 24 countries and accounting for 4.5% (n=1,812/40,620) of the included PIVCs. There was a low incidence of concurrent (multiple) PIVC use (<1%).
Participants had a median age of 61 years (IQR, 49–72) and 53% were male (Table 1). PIVCs were most frequently inserted in the general ward setting (75%) and the emergency department (12%). A majority of PIVCs were inserted by nurses (80%), with fewer inserted by doctors (8%) or IV teams (3%). The most common insertion sites were the forearm (37%) and hand (34%), followed by the wrist (12%) and antecubital fossa (12%). Only 17% of PIVCs were used for chemotherapy administration, and 8% were used for administration of blood products. The administration of fluids (58%) and other IV medications (64%) was more common. PIVCs were predominantly sized between 20G–24G (89%), with the preferred size being 22G (36%).
Table 1.
Patient and device insertion characteristics
| Participants (n=1,807) | Oncology/haematology n (%) |
| Age, median (IQR), years | 61 (49–72) |
| Male, gender, n(%) | 939 (53) |
| Devices (n=1,812) | |
| Primary insertion area n (%) ( * n=1,793) | |
| General ward/unit/clinic | 1,350 (75) |
| Emergency department | 215 (12) |
| Operating theatre | 54 (3) |
| Radiology/procedure room | 37 (2) |
| Intensive/critical care unit | 14 (1) |
| Ambulance/emergency services | 13 (1) |
| Other | 4 (0) |
| Unknown | 106 (6) |
| Primary inserter, n (%) | |
| Nurse | 1,458 (80) |
| Doctor | 146 (8) |
| IV team | 53 (3) |
| Technician | 33 (2) |
| Unknown | 122 (7) |
| Other | 0 (0) |
| Time of the day inserted n (%) | |
| Mon-Fri 7–5 | 689 (38) |
| Evening/night | 347 (19) |
| Weekend 7–5 | 165 (9) |
| Unknown | 611 (34) |
| PIVC dwell at assessment (Median (IQR), hours) | 24 (4–51) |
| PIVC dwell at assessment n (%) | |
| 0–24 hours | 583 (32) |
| 24–48 hours | 249 (14) |
| 48–72 hours | 127 (7) |
| >72 hours | 195 (11) |
| Unknown | 658 (36) |
| Devices (n=1,812) | Oncology/haematology n (%) |
| Reasons for PIVC insertion n (%) ^ | |
| IV medications | 1,159 (64) |
| IV fluids | 1,055 (58) |
| Chemotherapy | 304 (17) |
| Blood product transfusion | 146 (8) |
| Taking blood | 65 (4) |
| Parenteral nutrition | 41 (2) |
| Unstable/requiring resuscitation | 25 (1) |
| Unknown | 71 (4) |
| Primary PIVC size n (%) | |
| 14G | 5 (0) |
| 16G | 12 (0) |
| 18G | 126 (7) |
| 20G | 482 (27) |
| 22G | 660 (36) |
| 24G | 478 (26) |
| 26G | 2 (0) |
| Other | 7 (0) |
| Unknown | 40 (2) |
| Primary insertion site, n (%) | |
| Forearm | 672 (37) |
| Hand | 620 (34) |
| Wrist | 221 (12) |
| Antecubital fossa | 209 (12) |
| Upper arm | 53 (3) |
| Foot | 17 (1) |
| Other | 15 (1) |
| Unknown | 5 (0) |
Sample size <1,812 where missing data existed
Multiple selections could be made.
Signs and symptoms of complications were present in 12% of PIVCs (Table 2). The most common symptom of PIVC complication was pain/tenderness at the site of insertion (6%). Nine percent of PIVCs in cancer units were idle (i.e. not in use on the day of assessment). Dwell-time had the highest rate of missing data, with 36% of PIVC insertion times undocumented.
Table 2.
Device and patient outcomes
| Complications (n=1,812) | Oncology/haematology n (%) |
|---|---|
| Group size | n=1,812 |
| No clinical symptoms | 1,597 (88) |
| With clinical symptoms | 215 (12) |
| Phlebitis and infection | |
| Pain/tenderness | 102 (6) |
| Redness (>1cm) | 30 (2) |
| Swelling (>1cm) | 25 (1) |
| Palpable cord | 5 (<1) |
| Vein streak | 7 (<1) |
| Extravasation/infiltration | 4 (<1) |
| Induration/hardness (>1cm) | 4 (<1) |
| Purulence | 0 (0) |
| Malfunction | |
| Blood in line | 77 (4) |
| Bruising/dried blood | 42 (2.3) |
| Leaking | 12 (<1) |
| Partial/complete dislodgement | 4 (<1) |
| Skin reaction | |
| Itch/rash | 6 (<1) |
| Blistering/skin tears | 1 (<1) |
| PIVC not in use (on day of assessment) | 157 (9) |
Cancer units from various geographic regions (Africa, Asia, Australia/New Zealand, Europe, North America, and South America) were compared for differences in PIVC characteristics and complications; no notable differences were found. No cancer units in the Middle East or South Pacific contributed data to the larger study.
Multivariable modelling
In multivariable logistic models (Table 3), PIVC insertion by a doctor, compared with nurse-led insertion, was significantly associated with an increase in the presence of PIVC complications (OR 2.78, 95% CI 1.29–6.00, p≤0.01). PIVC insertions in emergency departments (OR 2.15, 95% CI 1.07–4.31, p=0.03) and ambulance/other/unknown units (OR 3.22, 95% CI 1.43–7.23, p≤0.01) vs. ward placement was were also associated with PIVC complications. Treatment factors, including the administration of colloids/blood products (OR 2.20, 95% CI 1.09–4.43, p=0.03) and IV anti-emetics (OR 1.94, 95% CI 1.18–3.18, p≤0.01), along with poor observed dressing integrity (not clean, dry and/or intact) (OR 3.58, 95% CI 2.30–5.58, p≤0.01) were also associated with increased risk of PIVC complications. Finally, incremental increases in dwell time from 49–72 hours (OR 6.55, 95% CI 3.03–14.18, p≤0.01) and >73 hours (OR 2.22, 95% CI 1.07–4.63, p=0.03), compared with those dwelling less than 24 hours, were associated with increased risk of PIVC complications.
Table 3.
Logistic multivariable regression modelling (univariable and multivariable)
| Variables | Complications n(%) | Univariable OR (95%CI) | p value | Multivariable (n=1,560) OR (95%CI) | p value |
|---|---|---|---|---|---|
| Age: mean(SD) (n=1,798) | 57.03 (18.46)* | 0.99 (0.98–1.00) | NS | 0.99 (0.99–1.01) | NS |
| Inserted by (n=1,812) | |||||
| Nurse | 109 (7.5) | Reference (group) | Reference (group) | ||
| Doctor | 24 (16.4) | 2.83 (1.51–5.32) | <0.01 | 2.78 (1.29–6.00) | <0.01 |
| Other | 26 (12.5) | 2.02 (1.15–3.53) | 0.02 | 1.56 (0.76–3.20) | NS |
| Where it was inserted (n=1,793) | |||||
| General ward | 97 (7.2) | Reference (group) | Reference (group) | ||
| ED | 22 (10.2) | 1.83 (1.05–3.19) | 0.03 | 2.15 (1.07–4.31) | 0.03 |
| ICU/OT/radiology | 18 (17.1) | 1.93 (0.99–3.76) | 0.05 | 1.83 (0.81–4.16) | NS |
| Ambulance/other/unknown | 22 (17.9) | 3.41 (1.89–6.19) | <0.01 | 3.22 (1.43–7.23) | <0.01 |
| Gender (n=1,803) | |||||
| Female | 91 (10.5) | Reference (group) | Reference (group) | ||
| Male | 66 (7.0) | 0.63 (0.44–0.90) | 0.01 | 0.56 (0.37–0.86) | <0.01 |
| PIVC position (n=1,807) | |||||
| Hand/wrist | 71 (8.4) | Reference (group) | Reference (group) | ||
| Lower arm | 57 (8.5) | 1.02 (0.69–1.51) | NS | 1.13 (0.71–1.81) | NS |
| CF | 22 (10.5) | 1.10 (0.62–1.93) | NS | 0.78 (0.39–1.57) | NS |
| Upper arm | 9 (10.6) | 1.44 (0.65–3.19) | NS | 1.77 (0.71–4.42) | NS |
| Gauge (n=1,772) | |||||
| 14–18G | 19 (13.3) | 1.25 (0.69–2.26) | NS | 0.73 (0.34–1.56) | NS |
| 22–24G | 101 (8.8) | Ref | Reference (group) | ||
| Bigger than 24G | 36 (7.4) | 0.88 (0.49–1.55) | NS | 1.15 (0.58–2.28) | NS |
| PIVC assessment documented in the last 24 hours (n=1,812) | |||||
| No | 85 (10.2) | Reference (group) | Reference (group) | ||
| Yes | 74 (7.5) | 0.66 (0.43–1.01) | NS | 0.60 (0.39–0.99) | 0.04 |
| PIVC dressing assessment (n=1,757) | |||||
| Clean, dry and intact | 95 (6.6) | Reference (group) | Reference (group) | ||
| Not clean, dry and intact | 63 (20.3) | 3.73 (2.54–5.49) | <0.01 | 3.58 (2.30–5.58) | <0.01 |
| Colloid/blood product fluids today (n=1,756) | |||||
| No | 136 (8.3) | Reference (group) | Reference (group) | ||
| Yes | 18 (16.1) | 2.15 (1.19–3.87) | 0.01 | 2.20 (1.09–4.43) | 0.03 |
| Anti-emetic medication today n=1,725) | |||||
| No | 106 (7.8) | Reference (group) | Reference (group) | ||
| Yes | 44 (12.3) | 1.58 (1.03–2.41) | 0.04 | 1.94 (1.18–3.18) | <0.01 |
| Chemotherapy medication today (n=1,725) | |||||
| No | 134 (9.4) | Reference (group) | Reference (group) | ||
| Yes | 16 (5.3) | 0.54 (0.30–0.96) | 0.04 | 0.71 (0.36–1.41) | NS |
| Time of the day inserted (n=1,812) | |||||
| Mon-Fri 7–5 | 47 (6.8) | Reference (group) | Ref | ||
| Weekend 7–5 | 21 (12.7) | 2.08 (1.13–3.83) | 0.02 | 1.38 (0.68–2.80) | NS |
| Evening/nights | 31 (8.9) | 1.48 (0.87–2.51) | NS | 1.18 (0.63–2.18) | NS |
| Unknown | 60 (9.8) | 1.50 (0.97–2.33) | NS | 1.26 (0.31–5.13) | NS |
| Dwell time (n=1,812) | |||||
| 0–24 hours | 27 (4.6) | Reference (group) | Ref | ||
| 25–48 hours | 21 (8.4) | 1.88 (1.00–3.51) | 0.05 | 1.27 (0.62–2.60) | NS |
| 49–72 hours | 25 (19.7) | 6.43 (3.36–12.32) | <0.01 | 6.55 (3.03–14.18) | <0.01 |
| >73 hours | 22 (11.3) | 2.83 (1.48–5.39) | <0.01 | 2.22 (1.07–4.63) | 0.03 |
| Unknown | 64 (9.7) | 2.30 (1.38–3.83) | <0.01 | 1.18 (0.28–4.89) | NS |
Mean(SD); NS Not significant <0.05
A documented PIVC assessment (in the previous 24 hours before study observation) was associated with decreased risk of PIVC complications (OR 0.60, 95% CI 0.39–0.99, p≤0.04), as did male gender (OR 0.56, 95%CI 0.37–0.86, p=<0.01).
Discussion
This sub-analysis is the first international study to demonstrate the state of PIVC characteristics and complications among hospitalised adults in cancer units. Overall, 12% of PIVCs in the cancer setting had signs and symptoms of complications. Pain and/or tenderness was the most common PIVC complication reported at the time of assessment (5.6%); this is consistent with a recent study identifying tenderness as the most frequently reported PIVC complication14. Notably, extravasation and infiltration (key concerns for the cancer population)7 were identified in four PIVCs (<1%). We cannot be certain, however, that extravasation injuries would not have occurred later, as the data report one time-point of assessment. Unfortunately, the true incidence of extravasation remains unclear; a review (2013) found reported rates of 0.1–39%15; it is likely these rate differences stem from definition inconsistencies, or poor documentation and reporting16.
Several modifiable risk factors were associated with an increased risk of PIVC complications. PIVC insertion by doctors demonstrated poorer outcomes compared with insertion by nurses. It is difficult to draw conclusions from this, however, as practices for ‘inserter’ ranged greatly, not only between facilities but also geographic regions, with some reporting a majority of doctor-inserted devices (e.g. Australia/New Zealand, 45%) compared with other regions where doctor-led insertions are rare (e.g. Europe, 9%)11. Furthermore, ‘vascular access specialists,’ hypothesised to improve PIVC insertion success and other outcomes17, were not differentiated in the larger study data.
PIVCs inserted in geographic locations where conditions may preclude optimal insertion technique, such as emergency and ambulance/other, were associated with more complications, compared with ward-inserted PIVCs. The authors postulate this may relate to urgency of insertion, and limitations on prospective and considered device selection (e.g. PIVC v. CVAD) based on the treatment required18. Increased dwell time was similarly associated with an increased risk of complications, as increased dwell time offers greater days of exposure to develop complications. High-level evidence continues to suggest that clinically indicated replacement, rather than routine replacement at dedicated time-points (e.g. 72 or 96 hours), should be incorporated as best practice19. Essential to this practice is consistent PIVC sitemonitoring and early removal where complications exist20. This is supported by our study which found the risk of complications decreased where a PIVC site assessment had been completed and documented in the last 24 hours.
The one-time dressing assessment found 18% of PIVCs to be ‘not clean, dry and/or intact.’ Arguably, dressing and securement integrity is one of the most important risk factors for PIVC failure, and one that is easily amenable to improvement. While PIVC dressing and securement methods are diverse and the optimal method is unknown21, focusing on integrity and early intervention for sub-optimal dressing and securement should be paramount in nursing practice.
Treatment factors including colloid/blood product and antiemetic administration were associated with PIVC complications; there may be several causes for this. Blood products, as a result of their viscosity (estimated to be 4.5 times standard normal saline viscosity), decrease flow rate through infusion tubing and peripheral catheters22, therefore, inadequate flushing following infusions may have resulted in later PIVC complications. Interestingly, this contrasted with findings of one study that found blood products prolonged PIVC dwell time, citing the possibility that pH balance played a role23. Further investigation is required to assess the impact of IV treatments on PIVC failure to better inform device selection and/or best practice for PIVC care. Finally, male gender was the single non-modifiable risk factor associated with a decreased risk of PIVC complications; this is consistent with previous research findings12,13,24, perhaps reflecting males’ larger veins and therefore smaller catheter-tovessel ratios.
Overall, the authors found a moderate rate of idle PIVCs in this cohort (9%). Despite being lower than the larger study cohort (14%),11 this is nonetheless concerning. While there is little evidence for the exact rate of PIVC-related BSI in a cancer population, overall risk of BSI and downstream complications is nevertheless extremely high, particularly among neutropenic patients25. As identifying modifiable sources of infection is key in BSI prevention25, prompt removal of invasive devices should be considered by all clinical staff caring for cancer patients. Similarly, staff should be aware of the implications of blood in PIVC lines, identified in 4% of devices, such as the development of fibrin sheath (and thrombosis) which enable establishment of bacteria on internal surfaces of polyurethane catheters26 and pose additional risk to an already vulnerable population.
Results may be limited as: (i) patients receiving care for cancer are not exclusively treated in cancer units; (ii) similarly, patients not receiving treatment for cancer may be placed in these units; and (iii) as an altered definition of complications was used, direct comparison cannot be made to the larger OMG study. Despite these limitations, results present an important, largescale description of the state of care in cancer units and may be used to inform future rigorous research into the improvement of PIVC care in this specific, high-risk population.
Acknowledgements
The authors would like to thank the hospital staff and patients internationally who participated in the OMG study. Full details are available in the online appendix of the original article.
Funding
This study received an investigator-initiated project grant from Griffith University and the University of Michigan. The authors wish to declare the OMG study received unrestricted investigator-initiated research grants from Becton Dickinson (BD), CareFusion and 3M. B Braun provided funds for professional translation of data collection tools into several languages. All funds were made payable to Griffith University or Western Sydney University and not to individual researchers. Dr. Friese was supported by the National Cancer Institute of the National Institutes of Health under award number P30CA046592.
Footnotes
Conflicts of interest
EĽs employer/affiliates (Griffith University and the University of Queensland) have received, on her behalf, from manufacturers of vascular access device products: an investigator-initiated research grant from Eloquest Healthcare and a scholarship for conference attendance supported by Angiodynamics. GRB reports investigator-initiated research grants, speaker fees and consultancy payments provided to Griffith University by product manufacturers (3M, Becton Dickinson) and education providers (Ausmed, Wolters Kluwer). NM reports that Griffith University or The University of Queensland has received on her behalf: investigator-initiated research grants and unrestricted educational grants from Becton Dickinson, Cardinal Health and Eloquest Healthcare, and consultancy payments for educational lectures/expert advice from Becton Dickinson and 3M. CMR’s employers (Griffith University or The University of Queensland) have received on her behalf: investigator-initiated research or educational grants from Becton Dickinson-Bard, Cardinal Health, Eloquest Healthcare, and consultancy payments for educational lectures/expert advice from 3M, Becton Dickinson-Bard. VC has received grant funding from the Agency for Healthcare Research and Quality, Blue Cross/Blue Shield of Michigan, and the National Institute for Health. EA’s employer (Western Sydney University) has received on his behalf from manufacturers of vascular devices and products: investigator-initiated research from BD-Bard, Cook Medical Flo Medical and consultancy payments for educational lectures/expert advice from 3M, Bard, BBraun, BD. MT and CF declare no relevant competing interests.
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