Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

Capital Medical University

Status: Completed

Conditions: Stroke, Acute

Treatments: Drug: Normobaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03620370

OPENS-1

Details and patient eligibility

About

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age≥18 and ≤ 80;
• Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
• Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
• Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
• NIHSS score≥6分
• Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
• 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

86 participants in 2 patient groups

NBO group

Experimental group

Description:

Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.

Treatment:

Drug: Normobaric oxygen therapy

Control group

No Intervention group

Description:

The participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.