Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Endovascular Treatment; Neuroprotection
• Intervention / Treatment: Other: Normobaric oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital of Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
No Intervention: EVT group; The Endovascular therapy group were given room air. And the patient will also be given endovascular therapy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale(NIHSS) Score	the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits	4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization
modified Rankin Scale score (mRS)	secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)	90 ± 14 days after randomization
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours	secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)	24 ± 12 hours after randomization
Barthel Index (BI)	secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);	90 ± 14 days after randomization
Revascularization on 24-hour follow-up imaging	secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3	24 ± 12 hours hours after randomization
Early neurologic deterioration	NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;	24 ± 12 hours after randomization
Symptomatic Intracerebral Hemorrhage	imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification	24± 12 hours hours after randomization
Mortality	clinical safety endpoint;	90 ± 14 days after randomization
Stroke recurrence	clinical safety endpoint;	90 ± 14 days，180 ± 30 days after randomization
The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score	secondary clinical efficacy endpoint, Quality of Life score; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	90 ± 14 days after randomization
Delta NIHSS	Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).	24 ± 12 hours after randomization
Percent change NIHSS	Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]	24 ± 12 hours after randomization
Cerebral infarct volume	Infarct volume is evaluated mainly through brain MRI(DWI) or CT	36 ± 12 hours after randomization

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Xunming Ji, MD, Xuanwu Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Stroke; Ischemic Stroke; Hyperoxia
• Other Study ID Numbers: OPENS-1A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No