- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602856
Point-of-care-ultrasound in Swiss Air Rescue Rega
The Benefits of Pre-hospital POCUS Examinations in Air Rescue
The aim of the study is, on the one hand, to objectively investigate the patient-oriented benefits of prehospital point-of-care ultrasound (POCUS) examinations under the conditions of the helicopter emergency medical services (HEMS) in Switzerland. On the other hand, the study will show what the diagnostic quality of prehospital POCUS examinations is and how emergency medical teams can be trained to use POCUS in the future.
HEMS crew members will answer a short online questionaire about how findings of their POCUS examination has influenced their medical treatment, diagnosis and selection of target hospital for the patient (primary outcome parameters).
In addition, a study nurse will query the findings of the in-hospital diagnostic tests and compare them with the findings of the pre-hospital POCUS examination. This will enable the investigators to evaluate the diagnostic quality of the prehospital POCUS examination and to identify which findings are often not recognised in the POCUS. The subjective satisfaction and assessment of the benefit of the POCUS examination by the respective users will also be recorded (secondary outcome parameters).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jürgen Knapp, Dr.
- Phone Number: +41765138342
- Email: juergen.knapp@insel.ch
Study Locations
-
-
Zurich
-
Zürich, Zurich, Switzerland
- Recruiting
- Swiss Air Rescue Rega
-
Contact:
- Jürgen Knapp, Dr.
- Phone Number: +41765138342
- Email: juergen.knapp@insel.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients in whom the treating Rega team uses POCUS pre-hospital
- existing written General Consent (with permission to use patient data for research)
Exclusion Criteria:
- Age <18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis
Time Frame: During HEMS mission, estimated to be on average of 30-60 minutes
|
Number of patients and clinical pictures/injuries of patients in whom the findings of prehospital POCUS influenced the further course of action with regard to diagnosis?
|
During HEMS mission, estimated to be on average of 30-60 minutes
|
|
Therapeutic interventions
Time Frame: During HEMS mission, estimated to be on average 30-60 minutes
|
Number of patients and clinical pictures/injuries of patients in whom the findings of prehospital POCUS influenced the further course of action with regard to therapeutic interventions (e.g.
pleural decompression, fluid therapy, medication)?
|
During HEMS mission, estimated to be on average 30-60 minutes
|
|
Transportation target
Time Frame: During HEMS mission, estimated to be on average 30-60 minutes
|
Number of patients and clinical pictures/injuries of patients in whom the findings of prehospital POCUS influenced the further course of action with regard to selection of the target hospital
|
During HEMS mission, estimated to be on average 30-60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Missed findings
Time Frame: 1 day
|
Number of findings and which findings are missed during prehospital POCUS?
|
1 day
|
|
Users' subjective assessment
Time Frame: 1 day
|
Personal assessment of the users with regard to the benefit for the patient and the applicability of prehospital POCUS on a numeric rating scale from 1 to 10 (1=no benefit, 10=maximum benefit)
|
1 day
|
|
Diagnostic quality
Time Frame: 1 day
|
Interrater reliability analysis with the target size Cohen's kappa between POCUS findings and findings of in-hospital imaging (ultrasound, conventional X-ray, computed tomography)?
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jürgen Knapp, Dr., Bern University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-01154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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