Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-28 @ 3:03 PM
Study NCT ID:
NCT03436095
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning
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': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-10', 'studyFirstSubmitDate': '2018-02-10', 'studyFirstSubmitQcDate': '2018-02-10', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bundle measures can solve the problem of difficult-weaning patients with Non neurogenic disease in ICU.', 'timeFrame': 'From June 1st 2017 to June 30 2020', 'description': "Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bundle', 'difficult ventilator weaning'], 'conditions': ['Weaning Failure']}, 'descriptionModule': {'briefSummary': "Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.", 'detailedDescription': 'Older than 16 years of age, ventilator therapy more than 1 weeks, Ventilator parameters meet the standard of ventilator removal, repeated more than 3 times SBT not successful, or within a short period of time within a week of successful weaning, no other new incentives to need ventilator support again, and delayed weaning from ventilator more than 1 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'difficult-weaning patients with Non neurogenic disease in ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOlder than 16 years of age, ventilator therapy more than 1 weeks,ventilator parameters up to Weaning standard, repeated more than 3 times Spontaneous Breathing Test(SBT) not successful, or within a short period of time within a week of successful weaning, no other new incentives to re machine induced delayed more than 1 months or more offline.\n\n\\-\n\nExclusion Criteria:\n\nMechanical ventilation patients who are clearly defined as neurological disorders or advanced tumor wasting diseases, as well as those without informed consent.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03436095', 'briefTitle': 'The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen Second People's Hospital"}, 'officialTitle': 'The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning', 'orgStudyIdInfo': {'id': '20173357201816'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'research group', 'description': 'bundle measures to help patient to weaning ventilator', 'interventionNames': ['Other: bundle measures']}, {'label': 'historical control group', 'description': 'retrospect the patients who were difficult to wean from ventilator and collect some materials to compare.', 'interventionNames': ['Other: bundle measures']}, {'label': 'External control group', 'description': 'contrast other same level hospitals measures to patients who are difficult to wean ventilator.', 'interventionNames': ['Other: bundle measures']}], 'interventions': [{'name': 'bundle measures', 'type': 'OTHER', 'description': 'Implementation of bundle measures to improve the successful rate of weaning ventilator', 'armGroupLabels': ['External control group', 'historical control group', 'research group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Guozhao', 'role': 'CONTACT', 'email': 'yangguozhao123@qq.com', 'phone': '+86075583003435'}], 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Feng Yongwen', 'role': 'CONTACT', 'email': '29206961@qq.com', 'phone': '13902471022'}], 'overallOfficials': [{'name': 'Meng Xinke', 'role': 'STUDY_DIRECTOR', 'affiliation': 'study principal investigator Shenzhen Second Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}