Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 1:51 PM
Study NCT ID:
NCT04967651
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of postoperative pulmonary complications', 'timeFrame': '1 week after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pulmonary Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or older who planned elective cardiac surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years or older;\n* Elective cardiac surgery under general anesthesia\n\nExclusion Criteria:\n\n* Patients and their family members refused to be enrolled;\n* Patients unable to communicate due to language barriers such as dementia;\n* Patients admitted to ICU 24h before surgery;\n* Estimated duration of surgery less than 2 hours;\n* Patients died or discharged within 24 hours after surgery'}, 'identificationModule': {'nctId': 'NCT04967651', 'briefTitle': 'Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Analysis of Risk Factors and Establishment and Application of a Clinical Early Warning Model for Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'PPC202106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with pulmonary complications following cardiac surgery'}, {'label': 'Patients without pulmonary complications following cardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingping Wu', 'role': 'CONTACT', 'email': 'wqp1968@163.com'}], 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qingping Wu', 'role': 'CONTACT', 'email': 'wqp1968@163.com', 'phone': '13971605283'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuhan Central Hospital', 'class': 'OTHER'}, {'name': 'Shanxi Cardiovascular Hospital', 'class': 'OTHER'}, {'name': "Qinghai People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}