Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

NCT05128422 | Completed

• 1 other identifier: OPENS-1A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Early neurologic improvement (ENI) at 24 hours

  ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\];

  24 ± 12 hours

Secondary Outcomes (13)

• National Institutes of Health Stroke Scale(NIHSS) Score

  4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization

• modified Rankin Scale score (mRS)

  90 ± 14 days after randomization

• Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

  24 ± 12 hours after randomization

• Barthel Index (BI)

  90 ± 14 days after randomization

• Revascularization on 24-hour follow-up imaging

  24 ± 12 hours hours after randomization

Study Arms (2)

NBO+EVT group

EXPERIMENTAL

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.

Other: Normobaric oxygen therapy

EVT group

NO INTERVENTION

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

Interventions

Normobaric oxygen therapy 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

NBO+EVT group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, MD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: October 27, 2021
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: July 31, 2024

Record last verified: 2023-10

Locations

CN (1)