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A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique

2014-07-24 14:10:26 | BioPortfolio

Summary

1. This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods.

2. This study will assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.

3. This study will assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.

Description

Patients agreeing to participate in this study will be randomized to one of two groups for intravenous access. One group will use the standard cannulation method and the other group will use the new FDA approved AccuVein AV300 device for cannulation.

After pre-anesthetic evaluation, the research participant will be brought to the operating room and standard monitoring will be applied (EKG, SpO2, BP) if tolerated. Anesthesia will be induced via a face mask with sevoflurane in 100% O2. When the supervising anesthesiologist deems it appropriate, attempt at cannulation will begin.

A tourniquet will be applied. A 22g cannula will be used. The anesthesiologist will choose a site (upper extremity/lower extremity) prior to randomization that s/he believes to be the best site for cannulation. The actual site and vein used will be left to the judgment of the anesthesiologist after randomization. If the research participant has been randomized to the standard treatment group then cannulation will be attempted in the standard manner. If the research participant has been randomized to the AV300 device group then intravenous cannulation will be attempted using the AV300 device following the manufacturer's instructions.

A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.

If the parent/guardian requests, s/he will be told after the procedure to which group the child was randomized.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Conditions

Cannulation

Intervention

Cannulation using Accuvein device, Standard Cannulation method

Location

St . Jude Children's Research Hospital
Memphis
Tennessee
United States
38105

Status

Recruiting

Source

St. Jude Children's Research Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:26-0400

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