Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-27 @ 3:38 AM
Study NCT ID:
NCT06517550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Complications in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the changes of oxygenation index', 'timeFrame': 'pre-surgery, leave-PACU, one-day after surgery and 7-day after surgery', 'description': "The patients' changes of Oxygenation index when leave-PACU, one-day after surgery and 7-day after surgery compared with pre-sugery oxygenation index"}], 'secondaryOutcomes': [{'measure': 'Incidence of pulmonary complications', 'timeFrame': '30 and 90 days after surgery', 'description': 'Incidence of pulmonary complications at 30 and 90 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA\\<III、 general anesthesia, 60-80 years, BMI\\<30kg/m2, pneumoperitoneum time\\>0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder)\n\nExclusion Criteria:\n\n* Severe anemia (Hb\\<60g/L), OSA, severe COPD (FEV1\\<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to ICU, heart function grade III-IV, severe liver and kidney dysfunction (Child B or C, dialysis), intraoperative bleeding greater than 30% of blood volume.'}, 'identificationModule': {'nctId': 'NCT06517550', 'briefTitle': 'Pulmonary Complications in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Effect of Protective Lung Ventilation Measures on Pulmonary Complications in Elderly Patients After Upper Abdominal Laparoscopy', 'orgStudyIdInfo': {'id': '2021-HX-54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'PEEP 5 cmH2O', 'description': 'During the surgical mechanical ventilation process, a constant PEEP value of 5 cmH2O is set.'}, {'type': 'EXPERIMENTAL', 'label': 'Personalized PEEP', 'description': "During surgical mechanical ventilation, individualized PEEP values are set based on each patient's lung condition.", 'interventionNames': ['Other: positive end-expiratory pressure while mechanical ventilation']}], 'interventions': [{'name': 'positive end-expiratory pressure while mechanical ventilation', 'type': 'OTHER', 'description': 'a parameter in ventilator', 'armGroupLabels': ['Personalized PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Feng X Ren, Professor', 'role': 'CONTACT', 'email': 'mxf0880@163.com', 'phone': '86+13331027233', 'phoneExt': '84205882'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jin J Zhang, doctor', 'role': 'CONTACT', 'email': 'zhangjinjing1989@163.com', 'phone': '86+15601318911', 'phoneExt': '010-84205566'}], 'overallOfficials': [{'name': 'Feng X Ren, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Janpan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'two years after the research and they will be available forever', 'ipdSharing': 'YES', 'accessCriteria': 'all researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jinjing Zhang', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}