- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01660724
Ultrasound Guided Arterial Puncture
August 2, 2013 updated by: Christian Borbjerg Laursen, Odense University Hospital
Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.
The main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is compared to conventional arterial puncture technique.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
238
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
-
-
Fyn
-
Odense, Fyn, Denmark, 5000
- Odense University Hospital
-
-
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
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient admitted or treated in the acute emergency department
- Indication for a arterial blood gas analysis, according to the physician responsible for the patient's hospital stay / treatment
Exclusion Criteria:
- Patient age < 16 years
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
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ultrasound guided arterial puncture
Patients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
|
Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
|
|
ACTIVE_COMPARATOR: Conventional arterial puncture technique
Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique
|
Arterial puncture is performed using the conventional technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis
Time Frame: up to 1 hour after arterial puncture
|
up to 1 hour after arterial puncture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time used for arterial puncture
Time Frame: up to 1 hour after arterial puncture
|
up to 1 hour after arterial puncture
|
|
|
Patient corporation
Time Frame: up to 1 hour after arterial puncture
|
Patient corporation is subjectively estimated by the physician performing the arterial puncture.
The degree of patient corporation are assessed on a scale from 1 - 5, where 1 is very poor patient corporation and 5 is perfect patient corporation.
|
up to 1 hour after arterial puncture
|
|
Pain Scores on the Visual Analog Scale
Time Frame: Up to 1 hour after arterial puncture
|
Up to 1 hour after arterial puncture
|
|
|
Number of attempts before successfully acquiring arterial puncture
Time Frame: up to 1 hour after arterial puncture
|
up to 1 hour after arterial puncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian B Laursen, MD, Odense Universityhospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2012
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
July 16, 2012
First Submitted That Met QC Criteria
August 8, 2012
First Posted (ESTIMATE)
August 9, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 5, 2013
Last Update Submitted That Met QC Criteria
August 2, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mulvarp2012
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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