NCT03006692

Brief 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. Furthermore it will be determined if the doctors find this device helpful in assessing and treating patients with affected consciousness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

December 27, 2016

Last Update Submit

May 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Will there be fewer observational diagnosis

    220 patients in 1.5 year

Secondary Outcomes (1)

  • Doctor satisfaction

    220 patients in 1.5 year

Study Arms (2)

Take arterial blood gas

Patients with impaired consciousness are randomised into having analysed a arterial blood gas.

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.

Interventions

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).

Take arterial blood gas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • GCS \< 13

You may not qualify if:

  • Pregnant or breastfeeding
  • detained or imprisoned patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, Odense, DK-5000, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Unconsciousness

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, ph.d.

Study Record Dates

First Submitted

December 27, 2016

First Posted

December 30, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations