- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462745
A Comparison of the First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Beginning of venous Cannulation until end of Cannulation, average of 1 min
|
Collaborators and Investigators
Investigators
- Principal Investigator: Roland N Kaddoum, MD, American University of Beirut Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ANES.RK.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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