AccuVein AV400 Device Versus Ultrasound-guided Cannulation of the Great Saphenous Vein at the Ankle in Infants

NCT04164862 | Unknown DMC

• 2 other identifiers: 0001209800018699
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Establishment of venousaccess in the age group ≤12 months can be difficult and associated with repetitive punctures . Numerous techniques to facilitate peripheral venous puncture have been described such as local warming, epidermal nitrogycerine, translumination, and venous cutdown . Ultrasound guidance is reported to facilitate peripheral venous catheterisation in children and to have advantages over blind techniques, especially for challenging veins . Also The AccuVein AV400 device which detects the haemoglobin in the vessels by red and infrared light reflection and shows a vasculature map. AccuVein AV400 device (AV400) improves the success rate of intravenous cannulation in pediatric patients . Most peripheral veins in infants are too superficial and too small for direct visualization. A promising alternative approach could be the great saphenous vein (GSV) at the level of the medial malleolus due to the adequate diameter and the relatively deep position relative to the skin.

Conditions

Intravenous Cannulation

Keywords

AccuVein AV400 device; ultrasound-guided cannulation

Outcome Measures

Primary Outcomes (1)

• the time to successful placement of catheters

  the time to successful placement of catheters

  "Through operation completion, average of 2 hours"

Secondary Outcomes (2)

• the number of attempts

  "Through operation completion, average of 2 hours"

• , technique-related pain, occurrence of movements, and occurrence of complications .

  "Through operation completion, average of 2 hours"

Study Arms (2)

use ACCUVEIN AV400

ACTIVE COMPARATOR

Device to facilitate cannulation of the great saphenous vein at the ankle in infants

Device: AccuVein AV400 Device Versus Ultrasound-guided Cannulation

ULTRASOUND GUIDED CANNULATION

ACTIVE COMPARATOR

Ultrasound cannulation of the great saphenous vein in infants

Device: AccuVein AV400 Device Versus Ultrasound-guided Cannulation

Interventions

AccuVein AV400 Device Versus Ultrasound-guided Cannulation DEVICE

Accuvein AV400 device versus Ultrasound guided cannulation

ULTRASOUND GUIDED CANNULATION; use ACCUVEIN AV400

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants' ≤12 months
• ASA physical status I and II
• undergoing elective surgery
• with no visible veins at the dorsum of the hands or feet

You may not qualify if:

• REFUSAL

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Rehab A.Zayed

Alexandria, 000000, Egypt

Location

Study Officials

• Rehab Zayed, Ass.Prof.

  Alexandria University

  PRINCIPAL INVESTIGATOR

• yasser Osman, Ass. Prof.

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Aneasthesia

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 15, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

EG (1)