Unconscious (Psychology)ABLNCT03006692
Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients
An observational study of Unconscious (Psychology), run by Odense University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unconscious (Psychology)
- What is being tested?
- With arterial blood gas, parameters not being normal can be corrected
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- GCS < 13
Who cannot join
- Pregnant or breastfeeding
- detained or imprisoned patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Unconscious (Psychology)
- Being tested
- With arterial blood gas, parameters not being normal can be corrected
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With arterial blood gas, parameters not being normal can be correctedOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Take arterial blood gas | Patients with impaired consciousness are randomised into having analysed a arterial blood gas. Receives: Other: With arterial blood gas, parameters not being normal can be corrected | |
| Do not take arterial blood gas | Patients with impaired consciousness are randomised into not having analysed a arterial blood gas. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Will there be fewer observational diagnosis
Measured: 220 patients in 1.5 year
Secondary outcomes (1)
Doctor satisfaction
Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis
Measured: 220 patients in 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unconscious (Psychology)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Zwisler, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006692
- Sponsor's protocol ID
- ABL Laegebil Odense
- Acronym
- ABL
- Status last verified
- May 2018
- First submitted
- 27 Dec 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zwisler ST, Zincuk Y, Bering CB, Zincuk A, Nybo M, Mikkelsen S. Diagnostic value of prehospital arterial blood gas measurements - a randomised controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Mar 18;27(1):32. doi: 10.1186/s13049-019-0612-8.
PubMed 30885262
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients
- ClinicalTrials.gov ID
- NCT03006692
- Acronym / sponsor ID
- ABL / ABL Laegebil Odense
- Conditions
- Unconscious (Psychology)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take arterial blood gas | – | Other: With arterial blood gas, parameters not being normal can be correctedPatients with impaired consciousness are randomised into having analysed a arterial blood gas. |
| Do not take arterial blood gas | – | –Patients with impaired consciousness are randomised into not having analysed a arterial blood gas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- GCS < 13
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- detained or imprisoned patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With arterial blood gas, parameters not being normal can be correctedIf 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). | Other | Take arterial blood gas |
Primary outcome
Diagnostic accuracy
Time frame: 220 patients in 1.5 year
Will there be fewer observational diagnosis
1 secondary outcome
Doctor satisfaction
Time frame: 220 patients in 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 30885262Zwisler ST, Zincuk Y, Bering CB, Zincuk A, Nybo M, Mikkelsen S. Diagnostic value of prehospital arterial blood gas measurements - a randomised controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Mar 18;27(1):32. doi: 10.1186/s13049-019-0612-8.
Related trials for Unconscious (Psychology)
Active, not recruitingPhase 2
Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)
Organ Transplant Failure or Rejection, Brain Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unconscious (Psychology), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 220 patients in 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.