Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-04 @ 11:42 PM
Study NCT ID:
NCT01757093
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2012-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of oxygen consumption through indirect calorimetry.', 'timeFrame': 'The measurement is during the spontaneous breathing trial, 30 minutes.', 'description': 'Measurements using indirect calorimetry for determination of oxygen consumption'}], 'secondaryOutcomes': [{'measure': 'Measurement of energy expenditure through indirect calorimetry', 'timeFrame': 'The measurement is during the spontaneous breathing trial, 30 minutes.', 'description': 'Measurement using indirect calorimetry for determination of energy expenditure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['INDIRECT CALORIMETRY', 'MECHANICAL VENTILATION', 'WEANING VENTILATOR', 'AUTOMATIC TUBE COMPENSATION'], 'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the oxygen consumption and energy expenditure during the spontaneous breathing trial.', 'detailedDescription': 'Patients is going to submit to the 2 spontaneous breathing trial ( Automatic tube compensation plus continuous positive airway pressure and continuous positive airway pressure without automatic tube compensation. The oxygen consumption and energy expenditure is going to measure during the spontaneous breathing trial by indirect calorimetry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IMPROVEMENT OR RESOLUTION OF THE UNDERLYING CAUSE OF DISEASE\n* INTUBATED PATIENTS\\>24h\n* PaO2 GREATER THAN 60 mmHg WITH FiO2 LESS THAN 40%\n* PEEP=5 cmH2O\n\nExclusion Criteria:\n\n* CARDIOVASCULAR INSTABILITY\n* FEBRILE OR HYPOTHERMIA\n* CHEST DRAINAGE\n* RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105\n* PREGNANCY\n* FAIL IN THE SPONTANEOUS BREATHING TRIAL\n* LEAKS IN THE CIRCUIT\n* AGITATION\n* NOT ACCEPT PARTICIPATE IN THE STUDY'}, 'identificationModule': {'nctId': 'NCT01757093', 'briefTitle': 'Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.', 'orgStudyIdInfo': {'id': 'AFL-0705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automatic tube compensation plus CPAP', 'description': 'The patients is going to undergo trials of spontaneous breathing with automatic tube compensation plus continuous positive airway pressure and later a trial with continuous positive airway pressure. During 30 minutes.', 'interventionNames': ['Device: Automatic Tube Compensation plus CPAP', 'Device: Continuous Positive Airway Pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Positive Airway Pressure', 'description': 'The patients is going to undergo a trial of spontaneous breathing with continuous positive airway pressure and later with automatic tube compensation plus continuous positive airway pressure, during 30 minutes each.', 'interventionNames': ['Device: Automatic Tube Compensation plus CPAP', 'Device: Continuous Positive Airway Pressure']}], 'interventions': [{'name': 'Automatic Tube Compensation plus CPAP', 'type': 'DEVICE', 'otherNames': ['ATC+CPAP'], 'description': 'SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP', 'armGroupLabels': ['Automatic tube compensation plus CPAP', 'Continuous Positive Airway Pressure']}, {'name': 'Continuous Positive Airway Pressure', 'type': 'DEVICE', 'description': 'SPONTANEOUS BREATHING TRIAL WITH CPAP', 'armGroupLabels': ['Automatic tube compensation plus CPAP', 'Continuous Positive Airway Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Alessandra Fa Lago, physiotherap', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ALESSANDRA FABIANE LAGO', 'investigatorFullName': 'Alessandra Fabiane Lago', 'investigatorAffiliation': 'University of Sao Paulo'}}}}