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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,176
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.
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.
the First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, China
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.
Time frame: On the postoperative 48th hour
pH value in blood gas analysis 48 hours after the operation
pH of blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48th hour
oxygen inhalation time
oxygen inhalation time
Time frame: On the postoperative 48 hour
inspired oxygen concentration
inspired oxygen concentration
Time frame: On the postoperative 48 hour
oxygen uptake rate
oxygen uptake rate
Time frame: On the postoperative 48 hour
7 days pulmonary complications
7 days pulmonary complications
Time frame: On the postoperative 7th day
30-day Mortality
30-day Mortality
Time frame: 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
Time frame: On the postoperative 48th hour
Lactic acid in blood gas analysis 48 hours after the operation
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Sichuan Provincial People's Hospital
Chendu, China
RECRUITINGChifeng Municipal Hospital
Chifeng, China
RECRUITINGDalian Third People's Hospital
Dalian, China
RECRUITINGFirst Affiliated Hospital, Dalian Medical University
Dalian, China
RECRUITINGFirst Affiliated Hospital of Harbin Medical University
Harbin, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, China
RECRUITINGFirst Medical University and Shandong Provincial Qianfoshan Hospital
Jinan, China
RECRUITINGFirst Affiliated Hospital of Kunming Medical University
Kunming, China
RECRUITING...and 6 more locations
Lactic acid in blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48th hour