Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-01 @ 5:27 AM
Study NCT ID:
NCT03237806
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054810', 'term': 'Deep Sedation'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No Masking'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Self control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-18', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2017-07-30', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MAP', 'timeFrame': '15 minutes', 'description': 'MAP during deep or light sedation'}], 'primaryOutcomes': [{'measure': 'Transpulmonary pressure generate by patient during deep or light sedation', 'timeFrame': '15 minutes during deep or light sedation', 'description': 'Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation'}], 'secondaryOutcomes': [{'measure': 'static compliance of respiratory system', 'timeFrame': '15min during deep or light sedation', 'description': 'Crs measured during deep or light sedation'}, {'measure': 'PaO2', 'timeFrame': '15 minutes', 'description': 'ABG after deep or light sedation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS,', 'Transpulmonary pressure,', 'Sedation'], 'conditions': ['ARDS']}, 'descriptionModule': {'briefSummary': "The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.", 'detailedDescription': 'Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:\n\n 1. Requires positive pressure ventilation through an endotracheal tube\n 2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days\n 3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days\n 4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine \\<10ug/kg•min or norepinephrine \\<10ug/kg)\n2. Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine \\<10ug/kg•min or norepinephrine \\<10ug/kg)\n\nExclusion Criteria:\n\n* Age younger than 18 years or older than 85 years\n* Cardiac failure\n* Known pregnancy\n* Increased intracranial pressure\n* Severe neuromuscular disease\n* Recent injury or other pathologic condition of the esophagus\n* Pneumothorax\n* Pleural effusion\n* Diaphragmatic hernia\n* Severe chronic respiratory disease\n* End-stage chronic organ failure\n* Expected survival of less than 24 hours\n* Participation in another interventional study\n* Attending physician declines to give consent for participant to enroll\n* Patient or surrogate declines or is unable to give consent'}, 'identificationModule': {'nctId': 'NCT03237806', 'acronym': 'ARDS', 'briefTitle': 'Effects of Sedation on Transpulmonary Pressure and Lung Homogenous', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients', 'orgStudyIdInfo': {'id': '2012ZDIIKY22.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Baseline', 'description': 'In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated'}, {'type': 'EXPERIMENTAL', 'label': 'Deep sedation', 'description': 'In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously', 'interventionNames': ['Drug: Deep sedated']}, {'type': 'EXPERIMENTAL', 'label': 'Light sedation', 'description': 'In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously', 'interventionNames': ['Drug: Light sedated']}], 'interventions': [{'name': 'Deep sedated', 'type': 'DRUG', 'otherNames': ['Deep sedation'], 'description': 'Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)', 'armGroupLabels': ['Deep sedation']}, {'name': 'Light sedated', 'type': 'DRUG', 'otherNames': ['Light sedation'], 'description': 'Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)', 'armGroupLabels': ['Light sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Songqiao Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Songqiao Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}