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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: 80% Oxygen | Placebo Comparator | 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. |
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| Experimental: 40% Oxygen | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 80% Oxygen | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation Index | 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. | On the postoperative 48th hour |
| Measure | Description | Time Frame |
|---|---|---|
| pH value in blood gas analysis 48 hours after the operation | pH of blood gas analysis 48 hours after the operation | On the postoperative 48th hour |
| oxygen inhalation time | oxygen inhalation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianhao Zhang, M.D. | Contact | +862483283100 | zhth774176947@163.com | |
| Yang An, M.D. | Contact | +862483283100 | cmu_ay2016@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41572351 | Derived | Zhang T, An Y, Zhao S, Han F, Huang L, Wang L, Wu J, Lei Q, Wang K, Shao J, Wang Y, Luan Y, Feng W, Song J, Huang Z, Wu C, Nan Y, Tang B, Sun X, Tan W. Effects of varying inhaled oxygen concentrations on lung function in older adult patients undergoing laparoscopic gastrointestinal surgery under general anesthesia: protocol of a prospective multicenter clinical study in China. Trials. 2026 Jan 23;27(1):139. doi: 10.1186/s13063-026-09471-3. |
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Study Protocol and Statistical Analysis Plan will be published
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| 40% Oxygen | Drug | 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. |
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| On the postoperative 48 hour |
| inspired oxygen concentration | inspired oxygen concentration | On the postoperative 48 hour |
| oxygen uptake rate | oxygen uptake rate | On the postoperative 48 hour |
| 7 days pulmonary complications | 7 days pulmonary complications | On the postoperative 7th day |
| 30-day Mortality | 30-day Mortality | On the postoperative 30th day |
| PaCO2 in blood gas analysis 48 hours after the operation | PaCO2 of blood gas analysis 48 hours after the operation | On the postoperative 48th hour |
| Lactic acid in blood gas analysis 48 hours after the operation | Lactic acid in blood gas analysis 48 hours after the operation | On the postoperative 48th hour |
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chendu | China |
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| Chifeng Municipal Hospital | Recruiting | Chifeng | China |
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| Dalian Third People's Hospital | Recruiting | Dalian | China |
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| First Affiliated Hospital, Dalian Medical University | Recruiting | Dalian | China |
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| First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | China |
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| First Medical University and Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | China |
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| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | China |
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| Affiliated Hospital of Qingdao University | Recruiting | Qingdao | China |
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| Liaoning Cancer Hospital and Institute | Recruiting | Shenyang | China |
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| Shenzhen People's Hospita | Recruiting | Shenzhen | China |
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| First Hospital of Hebei Medical University | Recruiting | Shijia Zhuang | China |
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| Second Hospital of Hebei Medical University | Recruiting | Shijia Zhuang | China |
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| YANBIAN University Hospital（Yanbian Hospital） | Recruiting | Yanbian | China |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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