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Effect of inspiratory oxygen fraction during lungprotective ventilation strategy on postoperative pulmonary complications in children: a randomized controlled trial

Effect of inspiratory oxygen fraction during lungprotective ventilation strategy on postoperative pulmonary complications in children: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106989
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None

Interventions

Experimental group:30% air-oxygen mixture
Control group:60% air-oxygen mixture

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age< 18 years old; 2. Planned elective non-thoracic surgery, requiring mechanical ventilation for more than 2 hours after general anesthesia intubation; 3. Have an American Society of Anesthesiologists (ASA) physical status class I to III.

Exclusion criteria

Exclusion criteria: 1. Planned laparotomy combined with intrathoracic surgery, or prone or lateral surgery; 2. Body mass index (BMI) more than 35kg/m^2; 3. History of pneumothorax, acute lung injury, or acute respiratory distress syndrome within the past 3 months; 4. Serious illness, including severe chronic obstructive pulmonary disease (COPD) (GOLD III or IV or home (non-invasive) ventilation and/or oxygen therapy), severe heart disease (New York Heart Association will be class III or IV), severe liver disease (eg, liver failure), chronic renal failure (renal failure (glomerular filtration rate< 30 mL min-1 1.73 m^2); 5. Chest imaging shows pneumothorax or megapulmonary blisters; 6. Mechanical circulatory support or reoperation is required after surgery; 7. Patients participating in any other clinical trial.

Design outcomes

Primary

MeasureTime frame
Atelectasis;

Secondary

MeasureTime frame
Respiratory tract infection;Aspiration pneumonia;Postoperative fever ( body temperature =37.5°C);The incidence of postoperative hypoxemia (SpO2 < 94%);Bronchospasm;Pleural effusion;Respiratory failure;

Countries

China

Contacts

Public ContactShao Huiying

Children's Hospital of Fudan University

252903641@qq.com+86 21 6493 1870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026