Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06602856
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Point-of-care-ultrasound in Swiss Air Rescue Rega
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis', 'timeFrame': 'During HEMS mission, estimated to be on average of 30-60 minutes', 'description': '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?'}, {'measure': 'Therapeutic interventions', 'timeFrame': 'During HEMS mission, estimated to be on average 30-60 minutes', 'description': '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)?'}, {'measure': 'Transportation target', 'timeFrame': 'During HEMS mission, estimated to be on average 30-60 minutes', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Missed findings', 'timeFrame': '1 day', 'description': 'Number of findings and which findings are missed during prehospital POCUS?'}, {'measure': 'Users' subjective assessment', 'timeFrame': '1 day', 'description': '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)'}, {'measure': 'Diagnostic quality', 'timeFrame': '1 day', 'description': '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)?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POCUS', 'Helicopter emergency medical service', 'Diagnostic quality'], 'conditions': ['Point-of-care-ultrasound', 'Emergency Treatment']}, 'descriptionModule': {'briefSummary': '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.\n\nHEMS 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).\n\nIn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients in whom the treating Rega team uses POCUS pre-hospital\n* existing written General Consent (with permission to use patient data for research)\n\nExclusion Criteria:\n\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT06602856', 'briefTitle': 'Point-of-care-ultrasound in Swiss Air Rescue Rega', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'The Benefits of Pre-hospital POCUS Examinations in Air Rescue', 'orgStudyIdInfo': {'id': '2024-01154'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Point-of-care ultrasound examination', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jürgen Knapp, Dr.', 'role': 'CONTACT', 'email': 'juergen.knapp@insel.ch', 'phone': '+41765138342'}], 'facility': 'Swiss Air Rescue Rega', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Jürgen Knapp, Dr.', 'role': 'CONTACT', 'email': 'juergen.knapp@insel.ch', 'phone': '+41765138342'}], 'overallOfficials': [{'name': 'Jürgen Knapp, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}