80% Oxygen
DrugAfter 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.
NCT Number: NCT06359106
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 4
the First Hospital of China Medical University, Shenyang, Liaoning, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: On the postoperative 48th hour
pH of blood gas analysis 48 hours after the operation
Time frame: On the postoperative 48 hour
oxygen inhalation time
Time frame: On the postoperative 48 hour
inspired oxygen concentration
Time frame: On the postoperative 48 hour
oxygen uptake rate
Time frame: On the postoperative 7th day
7 days pulmonary complications
Time frame: On the postoperative 30th day
30-day Mortality
Time frame: On the postoperative 48th hour
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
Contact information is provided by the study sponsor or research team.
Tianhao Zhang, M.D.
CONTACT
Yang An, M.D.
CONTACT
China Medical University, China
Other
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