Comparing oxygen levels during surgery in older patients

Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia

This study is testing whether giving older patients different levels of oxygen during laparoscopic surgery can improve their lung function and reduce complications after the procedure.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1176 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: China Medical University, China (other)
• Locations: 16 sites (Shenyang, Liaoning and 15 other locations)
• Trial ID: NCT06359106 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of different inhaled oxygen concentrations (40% vs. 80%) on lung function in older patients undergoing laparoscopic gastrointestinal surgery. The study is a multicenter, randomized controlled trial involving 1098 subjects aged over 65 years, who will be assigned to receive either low or high levels of oxygen during surgery. The primary outcome measure is the oxygenation index assessed 48 hours postoperatively, while secondary outcomes include postoperative pulmonary complications and mortality rates within 30 days. The study employs a lung-protective ventilation strategy to optimize respiratory parameters during the procedure.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 65 and above who are scheduled for laparoscopic gastrointestinal surgery and meet specific health criteria.

Not a fit: Patients with severe respiratory or cardiac conditions, or those requiring intensive care post-surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve postoperative lung function and reduce complications in older patients undergoing surgery.

How similar studies have performed: Previous studies have shown varying results with different oxygen concentrations, but this specific approach in older surgical patients is relatively novel.

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

Where this trial is running

Shenyang, Liaoning and 15 other locations

• the First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Beijing Friendship Hospital, Capital Medical University — Beijing, China (RECRUITING)
• Sichuan Provincial People's Hospital — Chendu, China (RECRUITING)
• Chifeng Municipal Hospital — Chifeng, China (RECRUITING)
• Dalian Third People's Hospital — Dalian, China (RECRUITING)
• First Affiliated Hospital, Dalian Medical University — Dalian, China (RECRUITING)
• First Affiliated Hospital of Harbin Medical University — Harbin, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, China (RECRUITING)
• First Medical University and Shandong Provincial Qianfoshan Hospital — Jinan, China (RECRUITING)
• First Affiliated Hospital of Kunming Medical University — Kunming, China (RECRUITING)
• Affiliated Hospital of Qingdao University — Qingdao, China (RECRUITING)
• Liaoning Cancer Hospital and Institute — Shenyang, China (RECRUITING)
• Shenzhen People's Hospita — Shenzhen, China (RECRUITING)
• First Hospital of Hebei Medical University — Shijia Zhuang, China (RECRUITING)
• Second Hospital of Hebei Medical University — Shijia Zhuang, China (RECRUITING)
• YANBIAN University Hospital（Yanbian Hospital） — Yanbian, China (RECRUITING)

Study contacts

• Study coordinator: Tianhao Zhang, M.D.

Conditions: Oxygenation Index