Clinical trial NCT06359106: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
Official title: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Oxygenation Index
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 1098
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxygenation Index
timeFrame: On the postoperative 48th hour
Secondary outcomes:
measure: pH value in blood gas analysis 48 hours after the operation
timeFrame: On the postoperative 48th hour
measure: oxygen inhalation time
timeFrame: On the postoperative 48 hour
measure: inspired oxygen concentration
timeFrame: On the postoperative 48 hour
measure: oxygen uptake rate
timeFrame: On the postoperative 48 hour
measure: 7 days pulmonary complications
timeFrame: On the postoperative 7th day
measure: 30-day Mortality
timeFrame: On the postoperative 30th day
measure: PaCO2 in blood gas analysis 48 hours after the operation
timeFrame: On the postoperative 48th hour
measure: Lactic acid in blood gas analysis 48 hours after the operation
timeFrame: On the postoperative 48th hour
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Chendu
country: China
facility: Sichuan Provincial People's Hospital
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
city: Dalian
country: China
facility: Dalian Third People's Hospital
city: Dalian
country: China
facility: First Affiliated Hospital, Dalian Medical University
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: First Medical University and Shandong Provincial Qianfoshan Hospital
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
city: Shenzhen
country: China
facility: Shenzhen People's Hospita
city: Shijia Zhuang
country: China
facility: First Hospital of Hebei Medical University
city: Shijia Zhuang
country: China
facility: Second Hospital of Hebei Medical University
city: Yanbian
country: China
facility: YANBIAN University Hospital（Yanbian Hospital）
Study officials:
References: