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

Cannulation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 or magnetic resonance imaging (MRI) Suite 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 22-gauge cannula will be used. Randomization will take place before the patient is taken back to the Operating Room or MRI Suite. 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.

Only the study coordinator will know which randomization group the patient has been assigned. Once the anesthesiologist has determined a potential IV access site, s/he will be informed to which group the patient was assigned. 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

Related Conditions & MeSH terms

• Cannulation

• NCT number: NCT01042613
• Study type: Interventional
• Source: St. Jude Children's Research Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Completion date: March 2011