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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01042613
First received: January 4, 2010
Last updated: November 2, 2011
Last verified: November 2011
  Purpose
  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.

Condition Intervention
Cannulation
Procedure: Cannulation using Accuvein device
Procedure: Standard Cannulation method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • First Attempt Success Rate of Cannulation [ Time Frame: At cannulation ] [ Designated as safety issue: No ]
    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:
  • Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). [ Time Frame: At cannulation ] [ Designated as safety issue: No ]
    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

  • Number of Skin Punctures [ Time Frame: At cannulation ] [ Designated as safety issue: No ]
    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


Enrollment: 146
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
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.
Group B
(standard technique of insertion of the intravenous cannula)
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042613

Locations
United States, Tennessee
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Luis Trujillo Huaccho, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01042613     History of Changes
Other Study ID Numbers: ACVEIN
Study First Received: January 4, 2010
Results First Received: September 9, 2011
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
AccuVein AV300 device;
Intravenous cannulation

ClinicalTrials.gov processed this record on November 24, 2014