protocolSection identificationModule nctId: NCT06359106, orgStudyIdInfo id: 2024.3.1, briefTitle: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, 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., conditionsModule conditions: Oxygenation Index, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1098, type: ESTIMATED, armsInterventionsModule interventions name: 80% Oxygen, interventions name: 40% Oxygen, outcomesModule primaryOutcomes measure: Oxygenation Index, secondaryOutcomes measure: pH value in blood gas analysis 48 hours after the operation, secondaryOutcomes measure: oxygen inhalation time, secondaryOutcomes measure: inspired oxygen concentration, secondaryOutcomes measure: oxygen uptake rate, secondaryOutcomes measure: 7 days pulmonary complications, secondaryOutcomes measure: 30-day Mortality, secondaryOutcomes measure: PaCO2 in blood gas analysis 48 hours after the operation, secondaryOutcomes measure: Lactic acid in blood gas analysis 48 hours after the operation, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fourth Affiliated Hospital of China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110001, country: China, contacts name: Ayong Tian, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: the First Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110001, country: China, contacts name: Wenfei Tan, M.D.,Ph.D, role: CONTACT, phone: 024-83283100, email: winfieldtan@hotmail.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Beijing Friendship Hospital, Capital Medical University, status: NOT_YET_RECRUITING, city: Beijing, country: China, contacts name: Yun Wang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sichuan Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Chendu, country: China, contacts name: Qian Shi, role: CONTACT, locations facility: Chifeng Municipal Hospital, status: NOT_YET_RECRUITING, city: Chifeng, country: China, contacts name: Jiannan Song, role: CONTACT, geoPoint lat: 42.26833, lon: 118.96361, locations facility: First Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqi, country: China, contacts name: Ke Wei, role: CONTACT, geoPoint lat: 27.00943, lon: 117.18179, locations facility: Dalian Third People's Hospital, status: NOT_YET_RECRUITING, city: Dalian, country: China, contacts name: Shiling Zhao, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: First Affiliated Hospital, Dalian Medical University, status: NOT_YET_RECRUITING, city: Dalian, country: China, contacts name: Yong Luan, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: First Affiliated Hospital of Harbin Medical University, status: NOT_YET_RECRUITING, city: Harbin, country: China, contacts name: Kun Wang, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Harbin Medical University Cancer Hospital, status: NOT_YET_RECRUITING, city: Harbin, country: China, contacts name: Fei Han, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: First Hospital, Jilin University, status: NOT_YET_RECRUITING, city: Jilin, country: China, contacts name: Xuesong Song, role: CONTACT, geoPoint lat: 43.85083, lon: 126.56028, locations facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine, status: NOT_YET_RECRUITING, city: Jinan, country: China, contacts name: Yongliang Chi, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: First Medical University and Shandong Provincial Qianfoshan Hospital, status: NOT_YET_RECRUITING, city: Jinan, country: China, contacts name: Jianbo Wu, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: First Affiliated Hospital of Kunming Medical University, status: NOT_YET_RECRUITING, city: Kunming, country: China, contacts name: Jianlin Shao, role: CONTACT, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Affiliated Hospital of Qingdao University, status: NOT_YET_RECRUITING, city: Qingdao, country: China, contacts name: Wei Feng, role: CONTACT, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Liaoning Cancer Hospital and Institute, status: NOT_YET_RECRUITING, city: Shenyang, country: China, contacts name: Zeqing Huang, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shenzhen People's Hospita, status: NOT_YET_RECRUITING, city: Shenzhen, country: China, contacts name: Chaoran Wu, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: First Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijia Zhuang, country: China, contacts name: Li Wang, role: CONTACT, geoPoint lat: 34.17775, lon: 109.84894, locations facility: Second Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijia Zhuang, country: China, contacts name: Lining Huang, role: CONTACT, geoPoint lat: 34.17775, lon: 109.84894, locations facility: Tianjin Fifth Central Hospital, status: NOT_YET_RECRUITING, city: Tianjin, country: China, contacts name: Shimin Shan, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, locations facility: YANBIAN University Hospital（Yanbian Hospital）, status: NOT_YET_RECRUITING, city: Yanbian, country: China, contacts name: Yongshan Nan, role: CONTACT, hasResults: False