Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 12:46 PM
Study NCT ID:
NCT03172169
Status:
UNKNOWN
Last Update Posted:
2017-06-06
First Post:
2017-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Small RNA in Plasma for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-04', 'studyFirstSubmitDate': '2017-05-29', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of diaphragmatic dysfunction using RT-PCR microRNA level', 'timeFrame': '7 days', 'description': 'Prediction of diaphragmatic dysfunction in patients with mechanical ventilation by specific minute RNA of plasma muscle tissue'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group, difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis and treatment', 'detailedDescription': '1. research content (1) screening MyomiR through literature review (2) selection of mechanical ventilation group, difficult withdrawal units and three healthy adult groups, method for the detection of plasma MyomiRX level and clinical assessment of diaphragmatic function, observation of the relationship between MyomiRX level and diaphragmatic dysfunction, prediction of plasma MyomiRX levels in patients with mechanical ventilation for diaphragmatic dysfunction in value.\n2. research objectives Objective to investigate the predictive value of specific minute RNA in plasma muscle tissue on diaphragmatic dysfunction in mechanical ventilation patients Experimental grouping (1) the control group of mechanical ventilation (time of examination, preoperative, admission to ICU and before extubation); (2) difficulty in withdrawal of units (first days, third days and seventh days after the failure of the test time for the first withdrawal); (3) the healthy control group (after the test time was selected)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for \\>48 hours and first SBT failure)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for \\>48 hours and first SBT failure)\n\nExclusion Criteria:\n\n1. severe respiratory depression, high paraplegia and neuromuscular lesions;\n2. esophageal obstruction, esophageal perforation, severe esophageal varices bleeding, upper gastrointestinal surgery and other reasons can not be placed EAdi catheter;\n3. thoracic deformity and diaphragmatic hernia;\n4. serious heart, liver, kidney and other organ failure, hemodynamic instability;\n5. pregnancy;\n6. the end of the tumor or the family member give up the active treatment'}, 'identificationModule': {'nctId': 'NCT03172169', 'briefTitle': 'Specific Small RNA in Plasma for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Observational Study of Specific Small RNA in Plasma Muscle Tissue for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'miRNA and Diaphragm'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy control group', 'description': 'no intervention', 'interventionNames': ['Other: no Intervention']}, {'label': 'Difficult withdrawal group', 'description': 'The mechanical ventilation time was \\>48 hours and the first SBT failure', 'interventionNames': ['Other: no Intervention']}, {'label': 'Mechanical ventilation control group', 'description': 'Elective and expected postoperative control of mechanical ventilation time greater than 12h after cardiothoracic surgery', 'interventionNames': ['Other: no Intervention']}], 'interventions': [{'name': 'no Intervention', 'type': 'OTHER', 'description': 'no Intervention', 'armGroupLabels': ['Difficult withdrawal group', 'Healthy control group', 'Mechanical ventilation control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'xu xiaoting, master', 'role': 'CONTACT', 'email': 'xuxiaoting2005@163.com', 'phone': '+86 13645188041'}], 'overallOfficials': [{'name': 'pan chun, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colleague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}