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

NCT03462745 | Completed Results

• 1 other identifier: ANES.RK.01
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Procedural Complication

Outcome Measures

Primary Outcomes (1)

• First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method

  Beginning of venous Cannulation until end of Cannulation, average of 1 min

Study Arms (2)

Cannulation with AccuVein AV 300

EXPERIMENTAL

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

Standard insertion

NO INTERVENTION

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

Interventions

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

Cannulation with AccuVein AV 300

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Results Point of Contact

• Title: Dr. Roland Kaddoum
• Organization: American University of Beirut Medical Center

rk16@aub.edu.lb

01350000

Study Officials

• Roland N Kaddoum, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Anesthesiology/ Director of Pediatric Anesthesia/ Director of Operating Room

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: February 10, 2013
• Primary Completion: February 10, 2014
• Study Completion: February 10, 2014
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02