A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
NCT ID: NCT01042613
Last Updated: 2011-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A
Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
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.
Group B
(standard technique of insertion of the intravenous cannula)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Luis Trujillo Huaccho, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St . Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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ACVEIN
Identifier Type: -
Identifier Source: org_study_id