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Clinical Trials in China / NCT06359106
Recruiting Phase 4

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

NCT06359106 · tracked via the Priya Life Science China tracker
Sponsor
China Medical University, China
Phase
Phase 4
Started
2024-07-02
Last updated
2026-01-26

Condition(s) studied

Oxygenation Index

Investigational drug(s) / intervention(s)

80% Oxygen40% Oxygen

80% Oxygen: After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.

40% Oxygen: After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
the First Hospital of China Medical University Shenyang Liaoning 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

More China Medical University, China trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06359106 on ClinicalTrials.gov ↗ ← All trials in China