NCT06602856

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress61%
Nov 2024May 2027

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

September 16, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

POCUSHelicopter emergency medical serviceDiagnostic quality

Outcome Measures

Primary Outcomes (3)

  • 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?

    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)?

    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

    During HEMS mission, estimated to be on average 30-60 minutes

Secondary Outcomes (3)

  • Missed findings

    1 day

  • Users' subjective assessment

    1 day

  • Diagnostic quality

    1 day

Interventions

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.

Eligibility Criteria

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

You may qualify if:

  • All patients in whom the treating Rega team uses POCUS pre-hospital
  • existing written General Consent (with permission to use patient data for research)

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Air Rescue Rega

Zurich, Canton of Zurich, Switzerland

RECRUITING

Study Officials

  • Jürgen Knapp, Dr.

    Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Knapp, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations