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

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.

Study Overview

• Status: Completed
• Conditions: Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
• Intervention / Treatment: Procedure: ultrasound guided central venous cannulation

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supraclavicular; ultrasound guided central venous cannulation done by supraclavicular approach	Procedure: ultrasound guided central venous cannulation; ultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis.
Experimental: infraclavicular; ultrasound guided central venous cannulation done by infraclavicular approach	Procedure: ultrasound guided central venous cannulation; ultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults	will be measured in seconds	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: INT/IEC/2015/321