Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries

Phase 4

Completed

• Conditions: Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound

• Registration Number: NCT02925715
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. In this study 96 Patients were randomized into one of the groups and compared for various outcomes. The primary outcome studied was the time taken for procedure. Secondary objectives included comparison of total access time using both the techniques,comparison of first attempt success rate, comparison of the quality of needle visualization and the comparison of immediate (mechanical) and delayed complication rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-09-30
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Healthy adults requiring central venous cannulation.

Exclusion Criteria

• History of prior catheterization.
• Limited sites for access attempts (other catheters, pacemaker, prior surgery).
• Previous difficulties during catheterization such as more than three punctures at one site, two sites attempted or failure to gain access.
• Previous mechanical complications during catheterization.
• Patients with infection at puncture site and contralateral pneumothorax.
• Patients with trauma to clavicle and upper ribs, distorted anatomy of neck or clavicles.
• Cervical spine injury.
• Known vascular abnormality.
• Untreated coagulopathy such as International Normalization Ratio(INR) ≥ 2, activated partial thromboplastin time >1.5 of normal or platelets <50,000/mm3
• After 3 attempts at needle puncture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults	1 year	will be measured in seconds

Secondary Outcome Measures

Name	Time	Method
total time taken for cannulation of veins using both the techniques.	1 year	measured in seconds
first attempt success rate	1 year	number of attempts taken will be measured
quality of needle visualisation	1 year	subjective visualisation of the needle on ultrasound will be noted as good or poor
immediate and delayed complications with the two approaches	1 year