Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04810520
Status:
WITHDRAWN
Last Update Posted:
2023-01-10
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No participants enrolled due to organizational problems', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of suspected diagnosis in comparison to clinical findings', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on accuracy of suspected diagnosis in comparison to clinical findings.'}], 'primaryOutcomes': [{'measure': 'Duration of prehospital ultrasound between POCUS with or without tele-supervision', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'duration of prehospital ultrasound between POCUS with tele-supervision and POCUS without tele-supervision in critically ill patients (acute dyspnoea, circulatory failure, trauma).'}], 'secondaryOutcomes': [{'measure': 'Alteration of treatent strategies', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on alteration of treatment strategies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound diagnostics', 'Prehospital emergency medicine'], 'conditions': ['Echocardiography', 'Telemedicine']}, 'descriptionModule': {'briefSummary': 'Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in emergency medicine for diagnosis and treatment of reversible causes. However, in prehospital setting performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on time to diagnosis of critically ill patients is unclear.\n\nAims: The aim of this study is to evaluate the impact of tele-supervision on the time of POCUS in prehospital critically ill patients by air rescue physicians.\n\nMethods: In total 100 critically ill patients suffering from acute dyspnoea, circulatory failure or trauma, which are treated by air rescue physicians will be included in this study. Duration of ultrasound performance as well as altered treatment strategies will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 critically ill patients with acute dyspnoea, circulatory failure or trauma, will be included in this study. In 50 patients POCUS with tele-supervision and in 50 patients POCUS without tele-supervision will be performed. Tele-supervision is available in 50% of the time. Allocation to one of the two groups depends on the availability of tele-supervision.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCritically ill patients suffering from acute dyspnoea, circulatory failure or trauma will be included.\n\nPatients with acute dyspnoea will be included, if they show at least one of the two following signs of respiratory failure:\n\n* Respiratory rate \\> 20 breaths per minute\n* Peripheral oxygen saturation without oxygen supplementation \\< 90%\n\nPatients with acute circulatory failure will be included, if they show at least one of the following signs:\n\n* Hypotension (systolic blood pressure \\<90mmHg)\n* Altered tissue perfusion (cold, clammy, mottling skin or altered mental status)\n\nTrauma patients will be included, if at least one cause is suspected:\n\n* Intraabdominal fluid\n* Intrathoracic free fluid\n* Pneumothorax\n\nExclusion Criteria:\n\n* age under 18\n* if POCUS will lead to a delay of live-saving treatment or transportation'}, 'identificationModule': {'nctId': 'NCT04810520', 'briefTitle': 'Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians', 'orgStudyIdInfo': {'id': '1218/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Point-of-care ultrasound with tele-supervision', 'description': 'Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.', 'interventionNames': ['Other: Point-of-care ultrasound with tele-supervision']}, {'label': 'Point-of-care ultrasound without tele-supervision', 'description': 'Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed without tele-supervision.', 'interventionNames': ['Other: Point-of-care ultrasound without tele-supervision']}], 'interventions': [{'name': 'Point-of-care ultrasound with tele-supervision', 'type': 'OTHER', 'description': 'Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.', 'armGroupLabels': ['Point-of-care ultrasound with tele-supervision']}, {'name': 'Point-of-care ultrasound without tele-supervision', 'type': 'OTHER', 'description': 'Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.', 'armGroupLabels': ['Point-of-care ultrasound without tele-supervision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Anaesthesia & General Intensive Care', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Department of Anaesthesia & General Intensive Care', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator', 'investigatorFullName': 'Christina Hafner', 'investigatorAffiliation': 'Medical University of Vienna'}}}}