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NCT02556541 Clinical Trial

Ultrasound-guided Peripheral Vascular Access in Children

Ultrasonography Clinical Trial

Official title:
Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02556541
Other study ID # 1-10-72-94-15
Secondary ID
Status Recruiting
Phase N/A
First received September 15, 2015
Last updated March 4, 2016
Start date September 2015

Study information
Verified date April 2015
Source University of Aarhus
Contact Nigopan Gopalasingam
Phone +45 31535950
Email 20103907@post.au.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:

1. Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.

2. Ultrasound guided cannulation by means of DNTP.

The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date August 2016
Accepts healthy volunteers
Gender Both
Age group N/A to 3 Years
Eligibility Inclusion Criteria:

- Requirement for anaesthesia before MRI or operation.

- Routine need of peripheral intravenous cannulation.

- Age 0- 3 years at the date of MR scan

Exclusion Criteria:

- Lack of consent

- Emergency patients needing immediate operation or scan.

Study Design

Intervention Model: Crossover Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• IV puncture guided by ultrasound

Locations
Country Name City State
Denmark Department of Anaesthesiology and Intensive Care Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary First attempt success Succes rate of first attempt cannulation for ultrasound and traditional method will be compared. Intraoperative
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