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Clinical Trials/NCT02925715
NCT02925715
Completed
Phase 4

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

Post Graduate Institute of Medical Education and Research, Chandigarh0 sites96 target enrollmentSeptember 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment
96
Primary Endpoint
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible Party
Principal Investigator
Principal Investigator

Dr Vikas Saini

Associate Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Outcomes

Primary Outcomes

puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults

Time Frame: 1 year

will be measured in seconds

Secondary Outcomes

  • total time taken for cannulation of veins using both the techniques.(1 year)
  • first attempt success rate(1 year)
  • quality of needle visualisation(1 year)
  • immediate and delayed complications with the two approaches(1 year)

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