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

NCT ID: NCT03462745

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-10
• Study Completion Date: 2014-02-10

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.

Conditions

Procedural Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AccuVein AV 300

Intervention Type: 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

Standard insertion

Intravenous cannulation is an invasive procedure of inserting an intravenous catheter blindly through the skin, into the lumen of a peripheral vein.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Roland Kaddoum

Associate Professor Department of Anesthesiology/ Director of Pediatric Anesthesia/ Director of Operating Room

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland N Kaddoum, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Other Identifiers

ANES.RK.01

Identifier Type: -

Identifier Source: org_study_id