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Led by China Medical University, China · Updated on 2026-01-26
1176
Participants Needed
16
Research Sites
N/A
Total Duration
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
Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 16 locations
1
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
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2
Beijing Friendship Hospital, Capital Medical University
Beijing, China
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3
Sichuan Provincial People's Hospital
Chendu, China
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4
Chifeng Municipal Hospital
Chifeng, China
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5
Dalian Third People's Hospital
Dalian, China
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6
First Affiliated Hospital, Dalian Medical University
Dalian, China
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7
First Affiliated Hospital of Harbin Medical University
Harbin, China
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8
Harbin Medical University Cancer Hospital
Harbin, China
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9
First Medical University and Shandong Provincial Qianfoshan Hospital
Jinan, China
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10
First Affiliated Hospital of Kunming Medical University
Kunming, China
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11
Affiliated Hospital of Qingdao University
Qingdao, China
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12
Liaoning Cancer Hospital and Institute
Shenyang, China
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13
Shenzhen People's Hospita
Shenzhen, China
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14
First Hospital of Hebei Medical University
Shijia Zhuang, China
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15
Second Hospital of Hebei Medical University
Shijia Zhuang, China
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16
YANBIAN University Hospital（Yanbian Hospital）
Yanbian, China
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T
Tianhao Zhang, M.D.
Y
Yang An, M.D.
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Tianhao Zhang, Yang An, Shiling Zhao...
https://pubmed.ncbi.nlm.nih.gov/41572351