- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556541
Ultrasound-guided Peripheral Vascular Access in Children
March 4, 2016 updated by: University of Aarhus
Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial
The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by:
- Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof.
- 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Recruiting
- Department of Anaesthesiology and Intensive care
-
Contact:
- Erik Sloth, professor, phd, MD
- Phone Number: 78 45 10 28
- Email: sloth@dadlnet.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Interventional Model: Crossover Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First attempt success
Time Frame: Intraoperative
|
Succes rate of first attempt cannulation for ultrasound and traditional method will be compared.
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
September 15, 2015
First Submitted That Met QC Criteria
September 18, 2015
First Posted (Estimate)
September 22, 2015
Study Record Updates
Last Update Posted (Estimate)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 4, 2016
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 1-10-72-94-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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