Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-29 @ 11:35 AM
Study NCT ID:
NCT02814994
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS', 'timeFrame': '28-days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mechanical Ventilation', 'ARDS', 'Ventilator Strategy', 'Outcome'], 'conditions': ['Respiratory Failure', 'Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.', 'detailedDescription': 'From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged ≥ 18 years\n2. admitted to the ICU\n3. according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS\n\nExclusion Criteria:\n\n1. age \\<18 years old\n2. be expected to die within 24 hours\n3. end-stage malignancies\n4. be participating in other studies, which may affect the results of this study\n5. DNI (do not intubation) and DNR (do not recovery) patients\n6. family members do not agree to sign an informed consent'}, 'identificationModule': {'nctId': 'NCT02814994', 'briefTitle': 'Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Respiratory System Compliance Guided Tidal Volume in Moderate to Severe ARDS Patients: A Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ARDS protocol treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tidal volume guided by respiratory system compliance', 'description': 'effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS', 'interventionNames': ['Behavioral: tidal volume guided by respiratory system compliance']}, {'type': 'EXPERIMENTAL', 'label': 'low tidal volume', 'description': 'Ventilated patients with low tidal volume', 'interventionNames': ['Behavioral: low tidal volume']}], 'interventions': [{'name': 'tidal volume guided by respiratory system compliance', 'type': 'BEHAVIORAL', 'description': 'ventilated with tidal volume guided by respiratory system compliance', 'armGroupLabels': ['tidal volume guided by respiratory system compliance']}, {'name': 'low tidal volume', 'type': 'BEHAVIORAL', 'description': 'ventilation ventilated with low tidal volume', 'armGroupLabels': ['low tidal volume']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Haibo Qiu, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'southeast university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician, Zhongda Hospital', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}