Skip to content

Effects of intraoperative oxygen fraction on cardiovascular outcomes after non-cardiac surgery in elderly patients with diabetes: a pilot randomised trial

Effects of intraoperative oxygen fraction on cardiovascular outcomes after non-cardiac surgery in elderly patients with diabetes: a pilot randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103711
Enrollment
Unknown
Registered
2025-06-04
Start date
2025-06-18
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

cardiovascular outcomes

Interventions

30%FiO2 group: FiO2 was set at 30%, maintaining SpO2=95%. Intervention duration: From intubation to pre-extubation.
80%FiO2 group: FiO2 was set at 80% immediately after intubation. Intervention duration: From intubation to pre-extubation.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years; 2. Previously diagnosed diabetes or newly diagnosed diabetes upon admission (fasting blood glucose >= 7.0 mmol/L, random blood glucose >= 11.1 mmol/L, or HbA1c >= 6.5%); 3. Scheduled non-cardiac surgery (major abdominal or orthopedic surgery) requiring general anesthesia with mechanical ventilation; 4. Expected surgical duration > 2 hours and postoperative hospital stay > 48 hours.

Exclusion criteria

Exclusion criteria: 1. Preoperative SpO2 < 90% or PaO2 < 60 mmHg without oxygen supplementation; 2. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis); 3. Planned one-lung ventilation during surgery; 4. History of chemotherapy within the past 3 months; 5. History of general anesthesia surgery within the past 30 days; 6. Perioperative need to continue medications known to cause significant myocardial injury; 7. Participant refusal or inability to obtain informed consent.

Design outcomes

Primary

MeasureTime frame
cardiovascular outcomes;

Secondary

MeasureTime frame
Acute kidney injury;Postoperative delirium;

Countries

China

Contacts

Public ContactLu Yang

Shanghai Sixth People's Hospital

y15722876306@163.com+86 157 2287 6306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026