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Study on the Efficacy of Normobaric Hyperoxia in Surgical Patients with Moyamoya Disease: A Prospective, Single-Center, Randomized Controlled Trial

Study on the Efficacy of Normobaric Hyperoxia in Surgical Patients with Moyamoya Disease: A Prospective, Single-Center, Randomized Controlled Trial - Normobaric Hyperoxia for Moyamoya Disease Surgery

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122532
Enrollment
Unknown
Registered
2026-04-14
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Moyamoya Disease

Interventions

Normobaric Hyperoxia Group:From intraoperative period (after anesthesia induction) to 4 hours postoperatively, patients inhaled 100% oxygen via a non?rebreathing mask at a flow rate of 10 L/min
for intubated patients, the fraction of inspired oxygen (FiO?) was set at 1.0.
Sham Control Group:Within the same time period, patients received low?flow oxygen at 1 L/min through identical?appearance masks
for intubated patients, FiO? was set at 0.3. The mask valves were kept open to mimic the sound of high?flow oxygen delivery.

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years; 2. Diagnosis of moyamoya disease (Suzuki Stage I–IV) confirmed by digital subtraction angiography (DSA) or magnetic resonance angiography (MRA); 3.Scheduled to receive combined cerebral revascularization surgery; 4. Preoperative modified Rankin Scale (mRS) score = 1; 5. Voluntary participation in this study with signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of severe cardiac, pulmonary, hepatic or renal insufficiency (e.g., chronic obstructive pulmonary disease, heart failure); 2.Requiring continuous high-flow oxygen therapy (>3 L/min) preoperatively to maintain SpO2 > 94%; 3. Complicated with active pulmonary infection or acute respiratory distress syndrome (ARDS); 4. Pregnant or breastfeeding women; 5. Expected survival duration < 90 days; 6. Any other conditions deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale Score;

Secondary

MeasureTime frame
NIHSS Scale;

Countries

China

Contacts

Public ContactLiming Zhao

Henan Provincial People's Hospital

lh410538@163.com+86 150 9006 2017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026