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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01042613
Recruitment Status : Completed
First Posted : January 5, 2010
Results First Posted : December 7, 2011
Last Update Posted : December 7, 2011
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 5, 2010
Results First Submitted Date  ICMJE September 9, 2011
Results First Posted Date  ICMJE December 7, 2011
Last Update Posted Date December 7, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
First Attempt Success Rate of Cannulation [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
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. [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
  • Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). [ Time Frame: 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
  • Number of Skin Punctures [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • 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. [ Time Frame: 18 months ]
  • 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 [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
Official Title  ICMJE A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Cannulation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Group A
    Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
    Intervention: Procedure: Cannulation using Accuvein device
  • Group B
    (standard technique of insertion of the intravenous cannula)
    Intervention: Procedure: Standard Cannulation method
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
146
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042613
Other Study ID Numbers  ICMJE ACVEIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luis Trujillo Huaccho, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP