Effects of High versus Low-concentration Normobaric Oxygen on Early Neurological Function in Acute Ischemic Stroke with Endovascular Therapy: Study Protocol for a Randomized Controlled Trial

Effects of High versus Low-concentration Normobaric Oxygen on Early Neurological Function in Acute Ischemic Stroke with Endovascular Therapy: Study Protocol for a Randomized Controlled Tria

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080227

Enrollment

Unknown

Registered

2024-01-24

Start date

2024-01-31

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

Acute ischemic stroke

Interventions

normobaric low-concentration oxygen (NBLO) group:Patients received 30% oxygen from the time they entered the operating room until they left .

normobaric high-concentration oxygen (NBHO) group :Patients received 80% oxygen from the time they entered the operating room until they left .

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: This trial included patients aged =18 years, with anterior circulation occlusive stroke confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), involving occlusions of the terminal internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA).

Exclusion criteria

Exclusion criteria: Subjects who meet one of the following criteria will be excluded: (1) stroke onset 6-24 h with a mismatched area < 15 ml as assessed by CT perfusion imaging (CTP), (2) NIHSS score = 5 at admission, (3) significant dysfunction before stroke (modified Rankin scale [mRS] =2). (4) Complicated with severe agitation and seizures, (5) evidence of intracranial hemorrhage at admission, (6) complicated with chronic obstructive pulmonary disease, obstructive sleep apnea and acute respiratory distress syndrome, (7) oxygen mask or ventilator must be used before anesthesia to maintain SpO2=94%, (8) loss of airway protective reflex or vomiting aspiration upon admission.

Design outcomes

Primary

Measure	Time frame
the incidence of early neurological improvement (ENI);	—

Secondary

Measure	Time frame
?NIHSS at 24 hours after onset;overall mRS distribution at 90 days;favorable functional outcome; early neurological deterioration (END);PPCs, defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax.;	—

Countries

China

Contacts

Public ContactZhengfang Hu

Anesthesiology Department of Beijing Tiantan Hospital,Capital Medical University

huzhengfang78@163.com+86 130 4108 4927

Outcome results

None listed

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