Comparison of safety and efficacy of ultrasound-guided supraclavicular and infraclavicular subclavian vein cannulation in intensive care unit patients: A randomized clinical study

Abstract

Background:

The aim of this study was to evaluate and compare the ease, difficulties, and complication rate of subclavian venous catheterization using the supraclavicular (SC) and infraclavicular (IC) approach under real-time ultrasound (USG) guidance in intensive care unit (ICU). The primary objective was to compare total procedure time during USG-guided subclavian vein catheterization.

Methods:

This was a prospective randomized comparative study. Eighty ICU patients of age >18 years of both genders requiring central venous catheterization were included in the study. Patients were randomly assigned to two groups using computer-generated random number table. USG guide central venous catheterization was done through SC approach in Group SC and through IC approach in Group IC after taking written consent.

Results:

The total procedure time was 304.5 ± 9.35 s in Group SC compared to 389.63 ± 18.04 s in Group IC (P < 0.001). The scanning time in SC approach was 85.60 ± 10.67 s and in IC approach 95.95 ± 11.22 s (P < 0.001). The needling time in Group SC was 30.88 ± 4.37 s compared to Group IC (33.08 ± 4.24 s) (P = 0.025). The quality of needle visualization was observed better in Group SC (82.5%) compared to Group IC (47.5%) (P = 0.001). The incidence of arterial puncture (20% vs. 5%), subcutaneous emphysema (2.5% vs. none), hematoma (12.5% vs. 5%), and pneumothorax (7.5% vs. none) has been observed in Group IC versus Group SC, respectively (P > 0.05).

Conclusion:

USG-guided SC approach of subclavian vein catheterization has shorter procedural time with better needle visualization and less complication rates than the IC approach.

INTRODUCTION

Central venous catheter (CVC) insertion has become an indispensable and routinely performed procedure in the field of modern medicine, particularly among patients who are critically ill and housed in intensive care units (ICUs), or those undergoing major surgical operations.[1] The use of CVC serves a dual purpose, being essential for both invasive monitoring and therapeutic interventions.[2,3] This critical role underscores its significance in contemporary medical practices, especially in settings involving acute and severe medical conditions.[4,5,6]

The IC approach to subclavian vein cannulation remains the traditional and most routinely practiced technique. However, emerging literature suggests that the SC approach offers several distinct advantages such as a high success rate and a commendable safety profile.[7,8,9]

Despite these advantages, there remains a notable gap in the literature concerning the comparative efficacy of these two approaches within the adult Indian population, particularly among critically ill ICU patients. Such information is crucial, as demographic and anatomical variations can influence the effectiveness and risk profile during both approaches.[7] Our research aimed to compare different procedural times and complication rate associated with the supraclavicular (SC) and infraclavicular (IC) approaches for subclavian venous catheterization under real-time ultrasound (USG) guidance in ICU patients.

METHODS

This prospective randomized single-blind study was conducted after approval from the institutional ethical committee [48/2022-23] and written consent from all patients. This study was registered in the Clinical Trials Registry-India [CTRI/2023/10/058552]. The sample size was calculated based on a previous study conducted by Prasad et al.[7] as references. It came out to be 80 patients (40 in each group) with 80% power of study and 95% confidence interval.

All patients underwent a thorough medical history assessment, comprehensive general and systemic examinations, as well as relevant clinical laboratory tests. Patients of age >18 years of both gender requiring CVC for therapeutic purpose or central venous pressure monitoring who were admitted to ICU whether mechanically ventilated or on spontaneous ventilation were included in the study. Exclusion criteria included patients’ or attendants’ refusal, an infection at the puncture site, pneumothorax, SVC syndrome, coagulation abnormality, distorted anatomy of the neck, right side chest injury or fracture clavicle, and patient having platelets count <50,000/µL. Patients were randomly assigned to two groups of 40 each using computer-generated random number table. The patients were unaware of the group assigned to them. All patients received ultrasound (USG)-guided CVC cannulation in the right subclavian vein in long axis view. The SC technique was applied in Group SC, while the IC technique was applied in Group IC.

All patients were placed in Trendelenburg position with 10–20° head down with rolled towel placed under their shoulders. The head was turned 30° to contralateral side. The right arm was adducted and pulled down gently toward the knee. The ultrasound machine was placed on the left side of the patient while operator stood at the right side of the patient. Electrocardiograph (ECG) electrodes, pulse oximeter, and blood pressure cuff were placed on the patients. To prevent subcutaneous emphysema and pneumothorax in mechanically ventilated patients, positive end-expiratory pressure (PEEP) pressure was set at <5 cm H₂O. Intravenous sedation and muscle relaxants were continued throughout the catheterization in mechanically ventilated patients. Intravenous sedation with 1 mg of midazolam was given before the procedure to patients who were spontaneously ventilating.

The procedure was done after taking all aseptic precautions. A triple lumen, 7Fr (16 G, 18 G,) 16 cm long CVC (Teleflex Arrow Three-Lumen CVC) was used in all the patients. Flushing of central catheters, needle, and dilator with heparinized saline was done. After proper positioning wide area around puncture site was exposed and washed with cleansing solution followed by alcohol base solution. Painting with betadine solution and draping was done. A linear vascular transducer (frequency 5–13 Hz) wrapped in sterile sheath with ultrasonic gel of the USG machine (Sonosite Fujifilm M-Turbo Medical System, USA) was placed at the anatomical landmarks to visualize the vein and 2D image displayed. Local infiltration was done at the puncture site with 2 mL of 2% lignocaine in all patients.

In Group SC, the claviculo-sternomastoid angle was identified either by asking the patient to raise their head or by palpation method. USG probe was kept on the lateral aspect of the right side of the neck area just above the clavicle to locate the internal jugular vein (IJV) and carotid artery. IJV was traced down the neck and after reaching the IJV-subclavian vein junction in SC fossa, the probe was turned 90° laterally to obtain a longitudinal view of the subclavian vein (SCV). The needle was introduced in long axis view directed at 45° angle to the sagittal and transverse planes aiming toward the contralateral nipple under USG guidance [Figure 1].

Figure 1.

USG probe orientation and view of supraclavicular approach during subclavian vein cannulation

In Group IC, USG probe was kept on the right side of the chest wall 1–1.5 cm below the middle and medial one-third of the clavicle. Initially, we located the subclavian vein in the short axis then by rotating the probe 90° laterally along the axis of the subclavian vein got a long axis visualization of the subclavian vein. The puncture needle was inserted through the skin just below the middle and medial one-third of the clavicle at 5°–10° angle from the horizontal approaching toward the suprasternal notch under USG visualization [Figure 2].

Figure 2.

USG probe orientation and view of infraclavicular approach of subclavian vein cannulation

In both approaches needle was introduced in plane under real-time USG guidance and the needle tip was visualized till it entered the vein and a free aspirate of blood was obtained in the syringe.

Catheterization process

Catheterization was completed using Seldinger method. After assessing the subclavian vein, the guidewire was advanced through the introducer needle. During this procedure, patients were monitored for any changes in ECG and other vitals of the patients. After the guidewire was successfully inserted, the introducer needle was removed and the dilator was passed over the guidewire till it reaches the wall of the subclavian vein. The dilator was then removed and the catheter, flushed with heparinized saline was placed over the guidewire. The catheter was sutured with 2.0 sterile silk with the patient skin. The sterile transparent dressing was applied. Postprocedure chest X-ray was done for confirmation.

All patients were followed up daily and the CVC insertion site was examined for infection or soiling. To prevent the postprocedural infections in the present study, a central venous catheter bundle was followed. To prevent venous thrombosis central venous catheter was flushed with heparin solution (1 unit per mL) 24 hourly. All observed complications were managed according to the standard clinical protocols. Hand hygiene procedures were strictly followed before and after injection, blood sampling, dressing, or any contact with the CVC or insertion site. If catheter tip colonization/infection or catheter-related bloodstream infection (CRBSI) were suspected, the CVC was removed and the tip of the catheter along with two sets of blood samples was sent for culture analysis. Patients were followed up for any new onset fever. If the patient recovered, discharged, or expired, CVC was removed and sent for culture.

Data collection

Demographic data of the ICU patients undergoing subclavian catheterization were recorded. Hemodynamic parameters were monitored and recorded at baseline, during catheterization, and after procedure. Different procedural times during the catheterization such as scanning time, needling time, catheter insertion time, and total procedure time were monitored by stopwatch and recorded. Intraprocedural complications were recorded. Quality of needle visualization during subclavian catheterization, first-pass success rate, total catheter insertion attempt, failure rate, and CVC in situ duration was monitored and recorded. Patients were followed up daily for data collection for postprocedural complication such as infection, venous thrombosis, or hemothorax.

Operational definitions

Scanning time was defined as time from the placement of the ultrasound probe on the patient’s skin to the clear visualization of the subclavian vein on the ultrasound screen, measured in seconds.

Needling time (subclavian vein puncture time): Indicating the duration from needle insertion to successful puncture of the subclavian vein, measured in seconds.

The success rate of subclavian vein cannulation was defined as successful placement of the catheter on the first or second attempt, and more than 2 attempts were considered as failure.

First-pass success (first-attempt success) was defined as successful placement of the catheter on the first attempt without repositioning the needle.

Catheter insertion time: Indicating the duration from successful puncture of the subclavian vein to catheter insertion, measured in seconds.

Total procedural time (total access time): Time taken from the application of the ultrasound probe until the successful insertion of the catheter, measured in seconds.

Catheter-related bloodstream infections were diagnosed through positive blood culture and symptoms of infection postcatheterization, associated with the catheter as confirmed by matching organisms in catheter tip and blood cultures.

Statistical analysis descriptive analysis of quantitative parameters was expressed as means and standard deviations. Categorical data were expressed as absolute number and percentage. Independent student’s t-test was used for testing of mean between independent groups and multivariate logistic regression test was used for calculation of procedural complications. Cross tables were generated, and Chi-square test was used for testing of associations of qualitative data. P <0.05 was considered statistically significant in the study. All analysis in the study was done using IBM SPSS software, version 25.0.

RESULTS

A total of 86 ICU patients for subclavian vein cannulation were enrolled in the study. Six patients were excluded from the study. Eighty patients were included in the study and were randomized into two groups, IC group (IC, n = 40) and SC group (SC, n = 40) [Figure 3].

Figure 3.

CONSORT flow diagram. IC: Infraclavicular, SC: Supraclavicular

The demographic parameters and mode of ventilation were comparable between the two groups, and the mean difference was statistically not significant [Table 1].

Table 1.

Demographic variables and mode of ventilation of the study participants

Variables	Group IC (n=40), n (%)	Group SC (n=40), n (%)	P
Age (year), mean±SD	43.05±12.57	42.03±9.7	0.684A
BMI (kg/m2), mean±SD	29.31±4.29	28.64±4.70	0.506A
Sex
Female	10 (25.0)	15 (37.5)	0.228B
Male	30 (75.0)	25 (62.5)
ASA physical status class
I	2 (5.0)	1 (2.5)	0.922B
II	7 (17.5)	6 (15.0)
III	9 (22.5)	10 (25.0)
IV	22 (55.0)	23 (57.5)
Mode of ventilation
Mechanical	32 (80.0)	31 (77.5)	0.347B
Spontaneous	8 (20.0)	9 (23.5)

^AIndependent t-test, ^BChi-square test. n: Number of patients, SC: Supraclavicular, IC: Infraclavicular, SD: Standard deviation, BMI: Body mass index, ASA: American Society of Anesthesiologists

The mean value of needle insertion attempts taken in Group IC was 1.38 ± 0.49 and in Group SC (1.20 ± 0.41), and the mean difference was statistically not significant (P = 0.086). Good needle visualization in the SC group was 82.5% and in the IC group 47.5% (P = 0.001). In the IC group, first-pass success was achieved in 57.5% of cases. In the SC group, first-pass success was achieved in 70% of cases. However, there was no statistically significant difference found between the groups (P = 0.245). The mean value of CVC in situ duration was significantly lower in the IC group as compared to the SC group (IC: 8.30 days; SC: 9.85 days; P < 0.001) [Table 2].

Table 2.

Difference in procedural variables between the groups

Variables	Group IC (n=40)	Group SC (n=40)	P
Needle insertion attempts, mean±SD	1.38±0.49	1.20±0.41	0.086A
Catheter insertion length (cm), mean±SD	12.55±0.5	12.03±0.42	<0.001A,*
CVC in situ duration (days), mean±SD	8.30±2.49	9.85±2.64	0.008A,*
Quality of needle visualization, n (%)
Good	19 (47.5)	33 (82.5)	0.001B,*
Poor	21 (52.5)	7 (17.5)
First-pass success rate, n (%)
No	17 (42.5)	12 (30.0)	0.245B
Yes	23 (57.5)	28 (70.0)

*Statistically significant, ^AIndependent t-test, ^BChi-square test. SC: Supraclavicular, IC: Infraclavicular, SD: Standard deviation, n: Number of patients

The scanning time of the subclavian vein in the SC approach was 85.60 ± 10.67 s while in the IC approach was 95.95 ± 11.22 s, and the mean difference was statistically significant (P < 0.001 s). Needling time of subclavian vein was shorter in the SC group (30.08 ± 4.37 s) compared to the IC group (33.08 ± 4.24 s), and the mean difference was statistically significant (P = 0.025). Catheter insertion time in the SC group was shorter (144.68 ± 11.38 s) than IC group (161.7 ± 13.36 s), and the mean difference was statistically significant (P = 0.025). Total procedural time was 304.5 ± 9.35 s in SC access and 389.63 ± 18.04 s for IC access, and the mean difference was statistically significant (P < 0.001) [Figure 4].

Figure 4.

Bar diagram showing the different procedural time (second) between the groups. IC: Mean infraclavicular, SC: Mean supraclavicular, SD: Mean standard deviation, n: Mean number of patients, Independent t-test, *P < 0.05: Statistically significant

In Group IC arterial puncture was found in 8 (20%) cases compared to 2 (5%) cases in Group SC. In the IC group, 9 (22.5%) patients developed arrhythmias as compared to 5% of cases in Group SC. Hematomas were observed in 5% of the SC group and 12.5% of the IC group (P = 0.285). Subcutaneous emphysema and pneumothorax showed no statistically significant differences between the groups with respective P = 0.359 and 0.24. There were no cases of venous thrombosis, air embolization, hemothorax, and malposition in both groups [Figure 5].

Figure 5.

Bar diagram showing intra-procedural complications between the groups. IC: Infraclavicular, SC: Supraclavicular, n: Number of patients, multivariate logistic regression test

DISCUSSION

In the present study, we have assessed the ease of catheterization of USG-guided subclavian vein in both SC and IC approaches with different parameters such as scanning time, needling time, catheter insertion time, total procedure time, quality of USG image of needle resolution during insertion, first-pass success rate, and needle insertion attempts and complications.

In the present study, the scanning time of the subclavian vein in SC approach was 85.60 ± 10.67 s, while in the IC approach, it was 95.95 ± 11.22 s (P < 0.001). The longer scanning time in the IC group might be because of the anatomic proximity of the vein to the clavicle and thereby difficulty in getting a longitudinal visualization because of the acoustic shadow of the clavicle.[9,10,11,12] Jaiswal et al.[13] in their study found scanning time to be significantly shorter in the SC group (17.97 ± 3.882 s) compared to the IC group (31.67 ± 6.266; P < 0.001). Prasad et al.[7] also reported lesser scanning time in the SC group (16.36 ± 2.64 s) compared to the IC group (22.10 ± 0.81 s; P < 0.0001).

In the present study, the needling time was shorter in Group SC (30.88 ± 4.37 s) compared to Group IC (33.08 ± 4.24 s), and the mean difference was statistically significant (P = 0.025). This could be because of the more superficial location of the subclavian vein in the SC approach.[13] Similar results were seen in the study of Prasad et al.[7] and Mageshwaran et al.[14] The catheter insertion time was also shorter (144.68 ± 11.38 s) in the SC group than IC group (161.7 ± 13.36 s), and the mean difference was statistically significant (P = 0.025). It could be because of the curve course of the subclavian vein and guidewire confirmation took additional time as the probe had to be moved to other areas to rule out guidewire misplacement in the ipsilateral IJV or brachiocephalic vein.[13] Similar results were seen in the study by Mageshwaran et al.[14] and Devi.[15] Total procedural time was significantly less in Group SC as compared to the IC group and it might be due to the anatomic proximity of the vein to the clavicle in IC approach. It was also difficult to get a longitudinal visualization in IC approach because of the acoustic shadow of the clavicle and to maintain the USG view of the vein and the needle simultaneously.[10,11] Jaiswal et al.[13] found a similar result and reported less procedural time in the SC group (270.77 ± 57.250 s) compared to the IC group (349.47 ± 78.236; P < 0.001). Prasad et al.[7] and Devi[15] also reported a similar result. Needle visualization in the SC group was better than the IC group, and this could be because of the less depth of the subclavian vein from the skin in the SC group as compared to the IC group. Saini et al.[16] also reported a similar result. The SC group achieved 70% success on the first attempt whereas 57.5% in the IC group (P = 0.245). Although this variable was statistically not significant, higher percentage of first-pass success in the SC group could be due to slightly better visualization of the subclavian vein.

In the present study, the hemodynamic parameters remained almost similar at different time intervals in both the groups.

In the present study, complications were lesser in Group SC. Arterial puncture was seen in 5% of cases of Group SC compared to 20% in Group IC (P = 0.108). Similar results were seen in the study by Devi[15] and Jaiswal et al.[13] Arrhythmias occurred in 5% of cases in the SC group compared to 22.5% in the IC group (P = 0.041). Devi[15] also reported a similar result that percentage of arrhythmia was higher in the IC group compared to the SC group. A higher incidence of arrhythmia in the IC group could be because of poor visualization. CRBSI was found in one case in the IC group (2.5%) compared to zero cases in the SC group (P = 0.359). The limited sample size of 80 patients might not provide sufficient to detect small differences in outcomes between the two approaches, especially for rare complications. All central venous catheterizations were performed on the right side of the subclavian vein; hence, study results might not be applied to left subclavian venous catheterization. Due to exclusion criteria, this study design did not account for potential confounders such as variations in patient anatomy, right side chest injury, or right clavicle bone fracture which could influence the success rate or risk of complications independently of the catheterization approach used. The relatively short follow-up period might not capture late-onset complications or long-term outcomes related to catheter use, such as late infections or catheter durability issues.

CONCLUSION

Real-time USG-guided SC approach of subclavian vein catheterization can be preferable alternative with significantly lesser total procedure time, similar success rate, and similar number of attempts taken and had lesser complication rates as compared to IC approach. These results indicate that the SC approach tends to be quicker and potentially more efficient in clinical settings.

Research quality and ethics statement

This study was approved by the Institutional Ethics Committee at UPUMS, Saifai (Approval #: 48/2022-23; Approval date: December 22, 2022). The study was prospectively registered with the Clinical Trials Registry-India (Registration #: CTRI/2023/10/058552; Registration date: Dec 12, 2023). The authors followed the applicable EQUATOR Network (http://www.equator-network.org/) guidelines, specifically the randomized clinical trials guidelines, during the conduct of this research project.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.