Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Capital Medical University

Status: Completed

Conditions: Endovascular Treatment; Stroke; Neuroprotection

Treatments: Other: Normobaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05128422

OPENS-1A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age≥18;
• Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
• Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
• NIHSS score≥6;
• Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
• (Level of consciousness) NIHSS score of 0 or 1
• mRS score was 0-1 before stroke;
• Informed consent obtained;

Exclusion criteria

• Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
• Seizures at stroke onset;
• Intracranial hemorrhage;
• Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
• Symptoms rapidly improving;
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
• Platelet count of less than 100,000 per cubic millimeter;
• CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
• severe hepatic or renal dysfunction;
• active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
• >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)#95% as per current stroke management guidelines;
• medically unstable;
• inability to obtain informed consent;
• Life expectancy<90 days;
• Pregnant or breast-feeding women;
• Unwilling to be followed up or poor compliance for treatment;
• Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
• Evidence of intracranial tumor;
• Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);
• Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks;
• Other circumstances requiring emergency oxygen inhalation;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

NBO+EVT group

Experimental group

Description:

Normobaric hyperoxia Combined with Endovascular therapy group were given 100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) . In addition, the patient will be given endovascular therapy surgery.

Treatment:

Other: Normobaric oxygen therapy

EVT group

No Intervention group

Description:

The Endovascular therapy group were given room air. And the patient will also be given endovascular therapy surgery.