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

Not Applicable

Completed

• Conditions: Cannulation
• Interventions: Procedure: Standard Cannulation method; Procedure: Cannulation using Accuvein device

• Registration Number: NCT01042613
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2011-09-09
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-02
• Last Update Submitted: 2011-11-02
• Results First Posted: 2011-12-07
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Infants and children under 18 years of age.
2. American Society of Anesthesiologist (ASA) Physical Status I, II or III.
3. Patients undergoing elective surgery,examination under anesthesia,or MRI who do not have existing intravenous access.
4. Able to understand English.
5. Parent/guardian willing to sign consent.

Exclusion Criteria

1. Existing intravenous access.
2. Malformations or infections at the potential site of insertion.
3. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
4. Need for emergency surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Standard Cannulation method	(standard technique of insertion of the intravenous cannula)
Group A	Cannulation using Accuvein device	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)

Primary Outcome Measures

Name	Time	Method
First Attempt Success Rate of Cannulation	At cannulation	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. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.

Secondary Outcome Measures

Name	Time	Method
Number of Skin Punctures	At cannulation	To 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
Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).	At cannulation	To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique

Trial Locations

Locations (1)

St . Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States