Comparing oxygen levels during surgery in older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Tianhao Zhang, M.D.
• Email: zhth774176947@163.com
• Phone: +862483283100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.