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Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Primary Purpose

Stroke, Endovascular Treatment, Neuroprotection

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Normobaric oxygen therapy

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Xuanwu Hospital of Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NBO+EVT group

EVT group

Arm 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.

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

Outcomes

Primary Outcome Measures

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];

Secondary Outcome Measures

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

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)

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)

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);

Revascularization on 24-hour follow-up imaging

secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3

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;

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

Mortality

clinical safety endpoint;

Stroke recurrence

clinical safety endpoint;

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.

Delta NIHSS

Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).

Percent change NIHSS

Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]

Cerebral infarct volume

Infarct volume is evaluated mainly through brain MRI(DWI) or CT

Full Information

NCT ID

NCT05128422

First Posted

October 28, 2021

Last Updated

July 3, 2023

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05128422

Brief Title

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 27, 2021 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Endovascular Treatment, Neuroprotection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NBO+EVT group

Arm Type

Experimental

Arm Description

Arm Title

EVT group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Normobaric oxygen therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Early neurologic improvement (ENI) at 24 hours

Description

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];

Time Frame

24 ± 12 hours

Secondary Outcome Measure Information:

Title

National Institutes of Health Stroke Scale(NIHSS) Score

Description

the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

Time Frame

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

Title

modified Rankin Scale score (mRS)

Description

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

Time Frame

90 ± 14 days after randomization

Title

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

Description

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)

Time Frame

24 ± 12 hours after randomization

Title

Barthel Index (BI)

Description

secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

Time Frame

90 ± 14 days after randomization

Title

Revascularization on 24-hour follow-up imaging

Description

secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3

Time Frame

24 ± 12 hours hours after randomization

Title

Early neurologic deterioration

Description

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;

Time Frame

24 ± 12 hours after randomization

Title

Symptomatic Intracerebral Hemorrhage

Description

imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

Time Frame

24± 12 hours hours after randomization

Title

Mortality

Description

clinical safety endpoint;

Time Frame

90 ± 14 days after randomization

Title

Stroke recurrence

Description

clinical safety endpoint;

Time Frame

90 ± 14 days，180 ± 30 days after randomization

Title

The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score

Description

Time Frame

90 ± 14 days after randomization

Title

Delta NIHSS

Description

Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).

Time Frame

24 ± 12 hours after randomization

Title

Percent change NIHSS

Description

Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]

Time Frame

24 ± 12 hours after randomization

Title

Cerebral infarct volume

Description

Infarct volume is evaluated mainly through brain MRI(DWI) or CT

Time Frame

36 ± 12 hours after randomization

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD

Phone

+86-10-83198952

jixm@ccmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji, MD

Organizational Affiliation

Xuanwu Hospital of Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuanwu Hospital of Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weili Li, MD

12. IPD Sharing Statement

Learn more about this trial

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

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