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

Recruiting now · Phase 4

Conditions studied: Oxygenation Index

In brief

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.

Key facts

Study ID

NCT06359106

Run by

China Medical University, China

People needed

1176

Starts

2024-07-02

Expected to finish

2026-06-30

Last updated by the study team

2026-01-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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