Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT06359106
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1098}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenation Index', 'timeFrame': 'On the postoperative 48th hour', 'description': 'The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'pH value in blood gas analysis 48 hours after the operation', 'timeFrame': 'On the postoperative 48th hour', 'description': 'pH of blood gas analysis 48 hours after the operation'}, {'measure': 'oxygen inhalation time', 'timeFrame': 'On the postoperative 48 hour', 'description': 'oxygen inhalation time'}, {'measure': 'inspired oxygen concentration', 'timeFrame': 'On the postoperative 48 hour', 'description': 'inspired oxygen concentration'}, {'measure': 'oxygen uptake rate', 'timeFrame': 'On the postoperative 48 hour', 'description': 'oxygen uptake rate'}, {'measure': '7 days pulmonary complications', 'timeFrame': 'On the postoperative 7th day', 'description': '7 days pulmonary complications'}, {'measure': '30-day Mortality', 'timeFrame': 'On the postoperative 30th day', 'description': '30-day Mortality'}, {'measure': 'PaCO2 in blood gas analysis 48 hours after the operation', 'timeFrame': 'On the postoperative 48th hour', 'description': 'PaCO2 of blood gas analysis 48 hours after the operation'}, {'measure': 'Lactic acid in blood gas analysis 48 hours after the operation', 'timeFrame': 'On the postoperative 48th hour', 'description': 'Lactic acid in blood gas analysis 48 hours after the operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxygenation Index']}, 'descriptionModule': {'briefSummary': 'This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.', 'detailedDescription': 'This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged \\> 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age not less than 65 years\n* American Society of Anesthesiologists grades I-III\n* No history of drug allergies or abnormal anesthesia.\n* The duration of mechanical ventilation was expected to be more than 2 hours.\n* Laparoscopic Gastrointestinal Surgery\n* The preoperative oxygen saturation was not less than 94%.\n* The patients will be planned to extubate in the operating room.\n\nExclusion Criteria:\n\n* History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.\n* Cardiac function Class IV (New York Heart Association classification)\n* Chronic renal failure (renal cell filtration rate \\<30 ml min-11.73/m2), severe liver disease\n* Patients with blurred consciousness and cognitive dysfunction\n* Severe coagulation dysfunction.\n* Without preoperative oxygen inhalation, blood oxygen level \\<94%, and severe pulmonary dysfunction\n* Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.\n* Body mass index (BMI) \\>30kg/m2\n* Inability to complete the study'}, 'identificationModule': {'nctId': 'NCT06359106', 'briefTitle': 'Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia', 'orgStudyIdInfo': {'id': '2024.3.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control: 80% Oxygen', 'description': 'Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. Blood will be collected for blood gas analysis within 48 hours after surgery.', 'interventionNames': ['Drug: 80% Oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: 40% Oxygen', 'description': 'Before anesthesia induction, the participants inhaled 100% oxygen through the mask for 3 minutes. After successful anesthesia induction, FiO2 will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute. All patients will receive treatment through the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8mL/kg, positive end-expiratory pressure (PEEP), 6-8 cmH2O; RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. However, when intraoperative oxygen saturation is less than 94%, the manual lung recruitment maneuver will also be performed. Patients should transfer to 80% Oxygen group if intraoperative oxygen saturation less than 85%.Blood will be collected for blood gas analysis within 48 hours after surgery.', 'interventionNames': ['Drug: 40% Oxygen']}], 'interventions': [{'name': '80% Oxygen', 'type': 'DRUG', 'description': 'After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.', 'armGroupLabels': ['Control: 80% Oxygen']}, {'name': '40% Oxygen', 'type': 'DRUG', 'description': 'After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.', 'armGroupLabels': ['Experimental: 40% Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenfei Tan, M.D.,Ph.D', 'role': 'CONTACT', 'email': 'winfieldtan@hotmail.com', 'phone': '024-83283100'}], 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Wang', 'role': 'CONTACT'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chendu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Lei', 'role': 'CONTACT'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.92504, 'lon': 121.03163}}, {'city': 'Chifeng', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiannan Song', 'role': 'CONTACT'}], 'facility': 'Chifeng Municipal Hospital', 'geoPoint': {'lat': 42.26833, 'lon': 118.96361}}, {'city': 'Dalian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiling Zhao', 'role': 'CONTACT'}], 'facility': "Dalian Third People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Dalian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Luan', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital, Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kun Wang', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Han', 'role': 'CONTACT'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianbo Wu', 'role': 'CONTACT'}], 'facility': 'First Medical University and Shandong Provincial Qianfoshan Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianlin Shao', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Qingdao', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Feng', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zeqing Huang', 'role': 'CONTACT'}], 'facility': 'Liaoning Cancer Hospital and Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chaoran Wu', 'role': 'CONTACT'}], 'facility': "Shenzhen People's Hospita", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shijia Zhuang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Wang', 'role': 'CONTACT'}], 'facility': 'First Hospital of Hebei Medical University', 'geoPoint': {'lat': 34.17775, 'lon': 109.84894}}, {'city': 'Shijia Zhuang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lining Huang', 'role': 'CONTACT'}], 'facility': 'Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 34.17775, 'lon': 109.84894}}, {'city': 'Yanbian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongshan Nan', 'role': 'CONTACT'}], 'facility': 'YANBIAN University Hospital（Yanbian Hospital）', 'geoPoint': {'lat': 36.41442, 'lon': 107.6096}}], 'centralContacts': [{'name': 'Tianhao Zhang, M.D.', 'role': 'CONTACT', 'email': 'zhth774176947@163.com', 'phone': '+862483283100'}, {'name': 'Yang An, M.D.', 'role': 'CONTACT', 'email': 'cmu_ay2016@163.com', 'phone': '+862483283100'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Study Protocol and Statistical Analysis Plan will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor,Chairman', 'investigatorFullName': 'Wenfei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}