Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT03433105
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of oxygen uptake (V̇O2)', 'timeFrame': 'up to 12 hours during the spontaneous breathing trial', 'description': 'oxygen uptake during the spontaneous breathing trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oxygen uptake', 'prolonged mechanical ventilation', 'weaning'], 'conditions': ['Ventilator Weaning']}, 'descriptionModule': {'briefSummary': "1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.\n\n1. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation\n2. Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials\n3. Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome\n\n2.Specific aims:\n\n1. to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation\n2. Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who have tracheostomy tubes and with prolonged mechanical ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion criteria:\n\n Adult \\>20 y/o Total duration of mechanical ventilation ≥ 10 days Received tracheostomy Defervescence Meeting the criteria of weaning phase (see supplementary protocols)\n2. Exclusion criteria FiO2 \\>50 % Unstable hemodynamics Fever with active infection No spontaneous respiratory drive Dynamic airway collapse'}, 'identificationModule': {'nctId': 'NCT03433105', 'briefTitle': 'Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'To Investigate the Prognostic Value of Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation', 'orgStudyIdInfo': {'id': '201710003RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1/patients with tracheostomy tubes and prolonged MV use', 'description': 'Patients who have tracheostomy tubes and with prolonged mechanical ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yao-Wen Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}