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OpenTrials
Completed

NCT Number: NCT02925715

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound guided central venous cannulation

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.

Primary outcomes

  1. 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

  1. total time taken for cannulation of veins using both the techniques.

    Time frame: 1 year

    measured in seconds

  2. first attempt success rate

    Time frame: 1 year

    number of attempts taken will be measured

  3. quality of needle visualisation

    Time frame: 1 year

    subjective visualisation of the needle on ultrasound will be noted as good or poor

  4. immediate and delayed complications with the two approaches

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.