Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 8:36 PM
Study NCT ID:
NCT04521933
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography', 'timeFrame': 'four weeks', 'description': 'Subjective assessment of Point-of-Care ultrasound records of the heart will be performed by participants via completion of the questionnaire. Thereafter, results of the survey will be compared with the objective measurements taken by conventional transthoracic echocardiography from the same records than presented in the questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transthoracic Echocardiography']}, 'referencesModule': {'references': [{'pmid': '25712077', 'type': 'BACKGROUND', 'citation': 'Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.', 'detailedDescription': 'Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability.\n\nPhysicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Physicians with at least basic knowledge of cardiac Point-of-Care ultrasound.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire\n\nExclusion Criteria:\n\n* not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04521933', 'briefTitle': 'Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic'}, 'officialTitle': 'Reliability of Subjective Qualitative Assessment of the Heart by Cardiac Point-of-Care Ultrasound in Comparison With Conventional Transthoracic Echocardiography', 'orgStudyIdInfo': {'id': '09/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Each participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart.\n\nEach participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40113', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masaryk Hospital Usti nad Labem', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}], 'overallOfficials': [{'name': 'Roman Skulec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masaryk Hospital Usti nad Labem'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk Hospital Usti nad Labem', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Roman Skulec', 'investigatorAffiliation': 'Masaryk Hospital Usti nad Labem'}}}}