Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
- Registration Number
- NCT06359106
- Lead Sponsor
- China Medical University, China
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1098
- Age not less than 65 years
- American Society of Anesthesiologists grades I-III
- No history of drug allergies or abnormal anesthesia.
- The duration of mechanical ventilation was expected to be more than 2 hours.
- Laparoscopic Gastrointestinal Surgery
- The preoperative oxygen saturation was not less than 94%.
- The patients will be planned to extubate in the operating room.
- History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months.
- Cardiac function Class IV (New York Heart Association classification)
- Chronic renal failure (renal cell filtration rate <30 ml min-11.73/m2), severe liver disease
- Patients with blurred consciousness and cognitive dysfunction
- Severe coagulation dysfunction.
- Without preoperative oxygen inhalation, blood oxygen level <94%, and severe pulmonary dysfunction
- Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery.
- Body mass index (BMI) >30kg/m2
- Inability to complete the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control: 80% Oxygen 80% Oxygen 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. Experimental: 40% Oxygen 40% Oxygen 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.
- Primary Outcome Measures
Name Time Method Oxygenation Index On the postoperative 48th hour 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.
- Secondary Outcome Measures
Name Time Method oxygen inhalation time On the postoperative 48 hour oxygen inhalation time
30-day Mortality On the postoperative 30th day 30-day Mortality
7 days pulmonary complications On the postoperative 7th day 7 days pulmonary complications
Lactic acid in blood gas analysis 48 hours after the operation On the postoperative 48th hour Lactic acid in blood gas analysis 48 hours after the operation
pH value in blood gas analysis 48 hours after the operation On the postoperative 48th hour pH of blood gas analysis 48 hours after the operation
oxygen uptake rate On the postoperative 48 hour oxygen uptake rate
PaCO2 in blood gas analysis 48 hours after the operation On the postoperative 48th hour PaCO2 of blood gas analysis 48 hours after the operation
inspired oxygen concentration On the postoperative 48 hour inspired oxygen concentration
Trial Locations
- Locations (16)
the First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Sichuan Provincial People's Hospital
🇨🇳Chendu, China
Chifeng Municipal Hospital
🇨🇳Chifeng, China
Dalian Third People's Hospital
🇨🇳Dalian, China
First Affiliated Hospital, Dalian Medical University
🇨🇳Dalian, China
First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
First Medical University and Shandong Provincial Qianfoshan Hospital
🇨🇳Jinan, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, China
Shenzhen People's Hospita
🇨🇳Shenzhen, China
First Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
YANBIAN University Hospital（Yanbian Hospital）
🇨🇳Yanbian, China