Comparing 40% and 80% Inhaled Oxygen Levels on Lung Function in Older Adults Undergoing Laparoscopic Gastrointestinal Surgery Under General Anesthesia
Led by China Medical University, China · Updated on 2026-01-26
1176
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different inhaled oxygen concentrations on lung function in older patients undergoing laparoscopic gastrointestinal surgery under general anesthesia. This multicenter, prospective, randomized controlled study compares low oxygen concentration 40% and high oxygen concentration 80% during surgery in patients aged 65 and older. The study aims to understand how these oxygen levels impact lung function and postoperative recovery.
Participants will be randomly assigned to one of two groups one receiving 80% oxygen and the other receiving 40% oxygen after anesthesia induction. Both groups will follow a lung-protective ventilation strategy with specific respiratory parameters. Manual lung recruitment maneuvers will be performed after intubation and before extubation. Blood samples for gas analysis will be collected within 48 hours after surgery to assess outcomes.
During the study, participants will be closely monitored with respiratory assessments and blood gas analyses, focusing on the oxygenation index 48 hours post-surgery. Secondary measures include pulmonary complications within 7 days and mortality within 30 days. The study involves multiple centers and plans to enroll 1098 subjects. The total duration of participation includes the surgical procedure and follow-up assessments up to 30 days after surgery.
CONDITIONS
Brief Title
Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
Research Team
T
Tianhao Zhang, M.D.
Y
Yang An, M.D.
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Classified as American Society of Anesthesiologists grades I to III
No history of drug allergies or abnormal anesthesia
Expected mechanical ventilation duration longer than 2 hours
Scheduled for laparoscopic gastrointestinal surgery
Preoperative oxygen saturation of at least 94%
Planned extubation in the operating room
You will not qualify if you...
History of acute lung injury or acute respiratory distress syndrome within 3 months
Cardiac function Class IV according to New York Heart Association classification
Chronic renal failure with filtration rate less than 30 ml/min/1.73 m2 or severe liver disease
Blurred consciousness or cognitive dysfunction
Severe coagulation dysfunction
Preoperative oxygen inhalation without blood oxygen level reaching 94% and severe pulmonary dysfunction
Admission to intensive care unit with endotracheal tubes after surgery
Body mass index greater than 30 kg/m2
Inability to complete the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of surgery and anesthesia
Participants receive general anesthesia for laparoscopic gastrointestinal surgery where they inhale either 40% or 80% oxygen concentrations during the operation. Lung-protective ventilation and manual lung recruitment maneuvers are used during surgery.
1 visit on surgery day (in-person)
Post-operative Follow-up
Duration - 30 days after surgery
Participants are monitored for lung function and complications after surgery, including blood gas analysis and assessment of pulmonary complications and mortality.
Visits on postoperative day 2, day 7, and day 30
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.