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A Comparison of the First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique

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ClinicalTrials.gov Identifier: NCT03462745
Recruitment Status : Completed
First Posted : March 13, 2018
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Roland Kaddoum, American University of Beirut Medical Center

Tracking Information
First Submitted Date  ICMJE February 28, 2018
First Posted Date  ICMJE March 13, 2018
Results First Submitted Date  ICMJE April 19, 2018
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE February 10, 2013
Actual Primary Completion Date February 10, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method [ Time Frame: Beginning of venous Cannulation until end of Cannulation, average of 1 min ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method [ Time Frame: One year ]
Patients who were randomized to AV300 (group A) and had an unsuccessful first attempt underwent the second attempt using the standard technique
Change History Complete list of historical versions of study NCT03462745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique
Official Title  ICMJE Randomized Cross Over Study Comparing the First Attempt Success Rate of Intravenous Cannulation in Children Using the AccuVein AV 300 Apparatus Versus the Standard Technique
Brief Summary

Background: The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.

Objectives: To assess the effectiveness of the AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation.

Methods: This was a prospective cross study of patients aged 0-18 years scheduled for surgery or examination under anesthesia but without having an existing IV access and after providing consent form. Patients were randomized into two groups; cannulation with AV300 or standard insertion performed by experienced pediatric anesthesiologists and residents under training.

Detailed Description Patients who fulfilled the inclusion criteria and provided informed consent were assigned to one of two groups using a randomization program that assigned research participants into group A (AccuVein AV300 assisted intravenous catheter insertion) or group B (standard technique of insertion of the intravenous cannula). After pre-anesthetic evaluation, the research participant was brought to the operating room and standard monitoring were applied (EKG, SpO2, BP) if tolerated. Anesthesia was induced via face mask with sevoflurane in 100% O2. The anesthesiologist and resident decided on a site believed to be the best for cannulation and on the size of the venous cannula as 22g or 24g. When the supervising anesthesiologist deemed it appropriate, the venous cannulation was attempted, according to the randomization groups, either with the AccuVein device (group A) or blindly (group B). A rating of the vein attempted as either difficult or easy was established by the attending anesthesiologist.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Procedural Complication
Intervention  ICMJE Device: AccuVein AV 300
Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the first-time success rate (SR) for pediatric patients who needed IV cannulation
Study Arms  ICMJE
  • Experimental: Cannulation with AccuVein AV 300
    The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.
    Intervention: Device: AccuVein AV 300
  • No Intervention: Standard insertion
    Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.
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: March 6, 2018)
184
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2014
Actual Primary Completion Date February 10, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients less than 18 years of age, American Society of Anesthesiologist Physical Status (ASA) status I, II or III, undergoing elective surgery or examination under anesthesia, which did not have existing intravenous access.

Exclusion Criteria:

  • Existing intravenous access, malformations or infections at the potential site of insertion, need for emergency surgery, and inability or unwillingness of parent or legal guardian to give written informed consent.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462745
Other Study ID Numbers  ICMJE ANES.RK.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Roland Kaddoum, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland N Kaddoum, MD American University of Beirut Medical Center
PRS Account American University of Beirut Medical Center
Verification Date February 2019

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