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

NCT ID: NCT02925715

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

supraclavicular

ultrasound guided central venous cannulation done by supraclavicular approach

Group Type: EXPERIMENTAL

ultrasound guided central venous cannulation

Intervention Type: PROCEDURE

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.

infraclavicular

ultrasound guided central venous cannulation done by infraclavicular approach

Group Type: EXPERIMENTAL

ultrasound guided central venous cannulation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Dr Vikas Saini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

INT/IEC/2015/321

Identifier Type: -

Identifier Source: org_study_id