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Effect of Oxygen Fraction and Recruitment Maneuvers on Postoperative Pulmonary Complications Among Patients Undergoing Abdominal Surgery: a multi-center, 2×2 factorial, randomized controlled trial

Effect of Oxygen Fraction and Recruitment Maneuvers on Postoperative Pulmonary Complications Among Patients Undergoing Abdominal Surgery: a multi-center, 2×2 factorial, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092953
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pulmonary complications

Interventions

Low FiO2 group:Received the lowest possible FiO2 that maintained intra-operative SpO2 of at least 94%, down to a minimum of 21%.
Low FiO2 and recruitment maneuvers group:Received the lowest possible FiO2 that maintained intra-operative SpO2 of at least 94% (down to a minimum of 21%) and standard recruitment maneuvers
High FiO2 group:Received 80% FiO2
80% FiO2 and recruitment maneuvers group:Received 80% FiO2 and standard recruitment maneuvers

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years; 2. ASA classification I-III; 3. With intermediate-high risk of pulmonary complications measured by the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score =26; 4. Scheduled for elective abdominal surgery under general anaesthesia and expected to be extubated; 5. Written inform consent.

Exclusion criteria

Exclusion criteria: 1. Had pneumothorax, subcutaneous emphysema, mediastinal emphysema, or bullae of lung 2. Persistent hemodynamic instability 3. Preoperative SpO2 = 94 in room air or partial pressure of carbon dioxide in artery > 45 mmHg; 4. With the history of severe chronic obstructive pulmonary disease (COPD, defined as GOLD grade of III - IV), pulmonary fibrosis, uncontrolled asthma, or FEV1/FVC = 70% 5. Had neuromuscular diseases (thymoma, myasthenia, myopathy, muscular dystrophy, etc.) 6. With the history of lung surgery 7. Pregnancy or lactation 8. Enrollment in another clincal study.

Design outcomes

Primary

MeasureTime frame
The incidence of pulmonary complications within the postoperative 7 days;

Secondary

MeasureTime frame
The incidence of hypoxemia within the 1 hour after extubation;Severity grade of pulmonary complications within the postoperative 7 days;The incidence of pulmonary complications within the postoperative 30 days;The incidence of re-intubation within the postoperative 30 days;The incidence of unplanned ICU admission within the postoperative 30 days;The all-cause mortality within the postoperative 30 days;

Countries

China

Contacts

Public ContactHai Yu

West China Hospital of Sichuan University

yuhai@scu.edu.cn+86 189 8060 1548

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 16, 2026