Point-of-care-ultrasoundNCT06602856
Point-of-care-ultrasound in Swiss Air Rescue Rega
An observational study of Point-of-care-ultrasound and Emergency Treatment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Point-of-care-ultrasound, Emergency Treatment
- What is being tested?
- Point-of-care ultrasound examination
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The Swiss Air Rescue Rega treats more than 12,000 patients annually. It is estimated that 1,000 of these will undergo a prehospital POCUS examination. These include both trauma patients and patients with medical diseases such as pulmonary oedema, COPD, myocardial infarction, etc.
Who may be able to join
- All patients in whom the treating Rega team uses POCUS pre-hospital
- existing written General Consent (with permission to use patient data for research)
Who cannot join
- Age \<18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Air Rescue Rega
Zurich, Canton of Zurich
Jürgen Knapp, Dr., +41765138342, juergen.knapp@insel.ch
About this study
Official title: 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).
- Conditions
- Point-of-care-ultrasound, Emergency Treatment
- Being tested
- Point-of-care ultrasound examination
- Keywords
- POCUS, Helicopter emergency medical service, Diagnostic quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound examinationOther
We are investigating the extent to which pre-hospital point-of-care ultrasound examination influences the further deployment tactics, medical treatment and choice of destination hospital for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis
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?
Measured: During HEMS mission, estimated to be on average of 30-60 minutes
Therapeutic interventions
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)?
Measured: During HEMS mission, estimated to be on average 30-60 minutes
Transportation target
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
Measured: During HEMS mission, estimated to be on average 30-60 minutes
Secondary outcomes (3)
Missed findings
Number of findings and which findings are missed during prehospital POCUS?
Measured: 1 day
Users' subjective assessment
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)
Measured: 1 day
Diagnostic quality
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)?
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point-of-care-ultrasoundStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Knapp, Dr., Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602856
- Sponsor's protocol ID
- 2024-01154
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Pre-hospital POCUS Examinations in Air Rescue
- ClinicalTrials.gov ID
- NCT06602856
- Acronym / sponsor ID
- 2024-01154
- Conditions
- Point-of-care-ultrasound, Emergency Treatment
- Keywords
- POCUS, Helicopter emergency medical service, Diagnostic quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Swiss Air Rescue Rega treats more than 12,000 patients annually. It is estimated that 1,000 of these will undergo a prehospital POCUS examination. These include both trauma patients and patients with medical diseases such as pulmonary oedema, COPD, myocardial infarction, etc.
Key inclusion criteria (2 listed)
- All patients in whom the treating Rega team uses POCUS pre-hospital
- existing written General Consent (with permission to use patient data for research)
Key exclusion criteria (1 listed)
- Age \<18 years
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 |
|---|---|---|
| Point-of-care ultrasound examinationWe are investigating the extent to which pre-hospital point-of-care ultrasound examination influences the further deployment tactics, medical treatment and choice of destination hospital for patients. | Other | – |
Primary outcome
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?
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)?
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
3 secondary outcomes
Missed findings
Time frame: 1 day
Users' subjective assessment
Time frame: 1 day
Diagnostic quality
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jürgen Knapp, Dr. principal investigator
Bern University Hospital
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 Point-of-care-ultrasound and Emergency Treatment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Knapp, Dr. (+41765138342, juergen.knapp@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: During HEMS mission, estimated to be on average of 30-60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.