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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

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.


Condition or disease Intervention/treatment Phase
Procedural Complication Device: AccuVein AV 300 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : February 10, 2013
Actual Primary Completion Date : February 10, 2014
Actual Study Completion Date : February 10, 2014

Arm Intervention/treatment
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.
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

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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462745


Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Roland N Kaddoum, MD American University of Beirut Medical Center

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Responsible Party: Roland Kaddoum, Associate Professor Department of Anesthesiology/ Director of Pediatric Anesthesia/ Director of Operating Room, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03462745     History of Changes
Other Study ID Numbers: ANES.RK.01
First Posted: March 13, 2018    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No