Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT04355559
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2020-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the data diaphragmatic ultrasound', 'timeFrame': 'When the intervention which is the first time to change the oxygen therapy', 'description': 'Record the data at the baseline and intervention'}], 'secondaryOutcomes': [{'measure': 'Arterial blood gas analysis results', 'timeFrame': 'When the intervention which is the first time to change the oxygen therapy', 'description': 'Record the data at the baseline and intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Ultrasound', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.', 'detailedDescription': '1. the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve.\n\ndiaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients older than 18 years without Invasive mechanical ventilation when entering the intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years\n* without Invasive mechanical ventilation when entering the intensive care unit.\n\nExclusion Criteria:\n\n* have noninvasive ventilation or high flow nasal cannula contraindications\n* history of neuromuscular disease chest wall deformities\n* previously assessed diaphragmatic palsy\n* shock or severe hemodynamic instability\n* known pregnancy, and/or need for immediate endotracheal intubation'}, 'identificationModule': {'nctId': 'NCT04355559', 'briefTitle': 'The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital', 'orgStudyIdInfo': {'id': '2018TM-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'conventional oxygen therapy', 'description': 'Continuous use of current oxygen therapy'}, {'label': 'high flow nasal cannula', 'description': 'change the oxygen therapy to high flow nasal cannula'}, {'label': 'Noninvasive ventilation', 'description': 'change the oxygen therapy to noninvasive ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lixin xie, doctor', 'role': 'CONTACT'}], 'facility': 'Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'ruoxuan wen, Respiratory therapist', 'role': 'CONTACT', 'email': '905508797@qq.com', 'phone': '15801216687'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'wang kaifei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}