Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

NCT ID: NCT05128422

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2023-10-15

Brief Summary

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.

Conditions

Stroke; Endovascular Treatment; Neuroprotection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NBO+EVT group

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.

Group Type: EXPERIMENTAL

Normobaric oxygen therapy

Intervention Type: OTHER

it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group

EVT group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Normobaric oxygen therapy

it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xunming Ji, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital of Capital Medical University

Locations

Xuanwu Hospital of Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

OPENS-1A

Identifier Type: -

Identifier Source: org_study_id