- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006692
Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients (ABL)
May 3, 2018 updated by: Stine Zwisler, Odense University Hospital
In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas testing is present since 2014.
This study will determine if a prehospital arterial blood gas helps the doctor to make more precise diagnosis prehospitally.
Furthermore it will be determined if the doctors find this device helpful in assessing and treating patients with affected consciousness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
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
-
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Odense
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Odense C, Odense, Denmark, DK-5000
- Odense University Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
220 patients seen prehospital by the mobile emergency care unit in Odense, Denmark.
Patients have to have impaired consciousness (Glasgow Coma Scale < 13).
Description
Inclusion Criteria:
- GCS < 13
Exclusion Criteria:
- Pregnant or breastfeeding
- detained or imprisoned patient
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Take arterial blood gas
Patients with impaired consciousness are randomised into having analysed a arterial blood gas.
|
If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g.
electrolytes, oxygenation and so forth).
|
Do not take arterial blood gas
Patients with impaired consciousness are randomised into not having analysed a arterial blood gas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 220 patients in 1.5 year
|
Will there be fewer observational diagnosis
|
220 patients in 1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Doctor satisfaction
Time Frame: 220 patients in 1.5 year
|
Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis
|
220 patients in 1.5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2016
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
December 27, 2016
First Submitted That Met QC Criteria
December 27, 2016
First Posted (Estimate)
December 30, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 3, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABL Laegebil Odense
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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