Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT03905460
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-care Ultrasound in Prehospital Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity for diagnosing heart failure', 'timeFrame': 'From initial citizen contact to end of ultrasound examination within 15 minutes', 'description': 'Change in sensitivity for diagnosing heart failure when adding point-of-care ultrasound to the clinical examination'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, clinical exam', 'timeFrame': 'From initial citizen contact and within a time-span of 15 minutes', 'description': 'Sensitivity of clinical examination for for diagnosing heart failure. Held up against a post-hoc expert panel statement.'}, {'measure': 'Sensitivity, Ultrasound examination', 'timeFrame': 'From initial citizen contact and within a time-span of 15 minutes', 'description': 'Sensitivity of clinical examination supplemented with ultrasound scan for diagnosing heart failure. Held up against a post-hoc expert panel statement.'}, {'measure': 'Treatment changes in medicine caused by ultrasound examination', 'timeFrame': 'From initial citizen contact and within a time-span of 15 minutes', 'description': 'Changes in medical treatment including diuretics, nitric oxide, bronkodilation and steroids caused by the addition of an ultrasound scan'}, {'measure': 'Treatment changes in ventilation caused by ultrasound examination', 'timeFrame': 'From initial citizen contact and within a time-span of 15 minutes', 'description': 'Treatment changes ventilatory strategy including nasal cannula oxygen therapi, face mask or non-invasive positive pressure ventilation caused by the addition of an ultrasound scan'}, {'measure': 'Triage changes caused by ultrasound examination', 'timeFrame': 'From initial citizen contact and within a time-span of 60 minutes', 'description': 'Change in the department or hospital that the patient is sent to as a cause of an ultrasound scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspnea']}, 'referencesModule': {'references': [{'pmid': '36740691', 'type': 'DERIVED', 'citation': 'Gundersen EA, Juhl-Olsen P, Bach A, Rostgaard-Knudsen M, Nielsen BRR, Skaarup SH, Petersen HO, Fjolner J, Poulsen MGG, Botker MT. PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study. Scand J Trauma Resusc Emerg Med. 2023 Feb 5;31(1):6. doi: 10.1186/s13049-023-01070-4.'}]}, 'descriptionModule': {'briefSummary': "Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Hence, there is a potential for correct diagnostics and appropriate treatment already in the citizens' own home or en route to the hospital. This study aims to evaluate the clinical performance of prehospital point-of-care ultrasound in patients with dyspnoea."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All citizens who have contacted the Acute Medical Coordination center in the Central Denmark Region for emergency medical treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>/= 18 years\n* dyspnea as a dominating complaint At least one of\n* respiratory frequency \\>25/minute\n* oxygen saturation \\< 95%\n* oxygen therapy initiated\n\nExclusion Criteria:\n\n* trama patients\n* prior enrollment'}, 'identificationModule': {'nctId': 'NCT03905460', 'briefTitle': 'Point-of-care Ultrasound in Prehospital Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Point-of-care Ultrasound in Prehospital Dyspnea: Game-changer or Gaming-gadgets?', 'orgStudyIdInfo': {'id': 'POC Ultrasound'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Point-of-care ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Focused ultrasound of the heart, lungs and pleurae'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Præhospitalet', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Morten Bøtker, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prehospital of Central Denmark Region'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Randers Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Thingemann Bøtker', 'investigatorAffiliation': 'University of Aarhus'}}}}