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OpenTrials
Completed

NCT Number: NCT03462745

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

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AccuVein AV 300

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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