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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01042613
Other study ID # ACVEIN
Secondary ID
Status Completed
Phase N/A
First received January 4, 2010
Last updated November 2, 2011
Start date January 2010
Est. completion date March 2011

Study information

Verified date November 2011
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Procedure:
Cannulation using Accuvein device
If the research participant has been randomized to the AV300 device group A, then intravenous cannulation will be attempted using the AV300 device following manufacturer's instructions by four anesthesiologists.
Standard Cannulation method
If the research participant has been randomized to the standard treatment group B then cannulation will be attempted in the standard manner. 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.

Locations

Country Name City State
United States St . Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary First Attempt Success Rate of 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. At cannulation No
Secondary Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). 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 At cannulation No
Secondary Number of Skin Punctures 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 At cannulation No
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