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Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

Primary Purpose

Stroke, Acute, Neuroprotection, Endovascular Treatment

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Normobaric Hyperoxia (NBO)

Low flow oxygen

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

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

Inclusion Criteria:

Symptoms and signs were consistent with acute anterior circulation stroke,
NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
Met the indications for endovascular therapy;
(Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
The time from onset to randomization was within 24 hours;
Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
Patients and their families signed informed consent

Exclusion Criteria:

Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
Seizures at stroke onset;
Intracranial hemorrhage;
Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
Platelet count of less than 100,000 per cubic millimeter;
Severe hepatic or renal dysfunction;
Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg)
Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 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;
Life expectancy<90 days;
Patients who could not complete the 90-day follow-up;
Evidence of intracranial tumor;
Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
A history of severe allergies to contrast agents;

Sites / Locations

Tianjin Huanhu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Low flow oxygen group

NBO group (2h)

NBO group (4h)

NBO group (6h)

Arm Description

patients were randomized into the Low flow oxygen group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

patients were randomized into the NBO group (2h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 2 hours.

patients were randomized into the NBO group (4h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

patients were randomized into the NBO group (6h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 6 hours.

Outcomes

Primary Outcome Measures

Cerebral infarct volume

The infarct volume is evaluated by MRI or CT scan

Secondary Outcome Measures

Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits)

The proportion of good prognosis

the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death;with higher scores indicating more severe disability);The ratio of 0 to 2;

neurological function improvement rate

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);

modified Rankin Scale score (mRS) score

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

Vascular recanalization rate

secondary imaging efficacy endpoint; Extended Treatment In Cerebral Ischemia (eTICI)；The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory; eTICI 2B or 3 are defined as successful recanalization;

blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc

Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:

Incidence of oxygen-related adverse events

Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;

Incidence of 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;

Incidence of 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

Incidence of any intracranial hemorrhage

imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

all-cause death rate

clinical safety endpoint; Ratio of total deaths from all causes to all enrollments

Incidence of adverse events

clinical safety endpoint;

Incidence of surgery-related complications

clinical safety endpoint;

stroke related death rate

clinical safety endpoint; Stroke-related deaths as a proportion of all participants

Vital signs:respiration(times/min)

clinical safety endpoint;

Vital signs:heart rate: (times/min)

clinical safety endpoint;

Vital signs:blood pressure(mmHg)

clinical safety endpoint;

Vital signs:oxygen saturation (%)

clinical safety endpoint;

Full Information

NCT ID

NCT05404373

First Posted

May 24, 2022

Last Updated

August 28, 2023

Sponsor

Capital Medical University

Collaborators

Tianjin Huanhu Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05404373

Brief Title

Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

Official Title

The Efficacy and Safety of Normobaric Hyperoxia on Treatment Duration for Acute Ischemic Stroke Patients With Endovascular Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 20, 2022 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

Collaborators

Tianjin Huanhu Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.

6. Conditions and Keywords

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

Stroke, Acute, Neuroprotection, Endovascular Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low flow oxygen group

Arm Type

Placebo Comparator

Arm Description

Arm Title

NBO group (2h)

Arm Type

Experimental

Arm Description

Arm Title

NBO group (4h)

Arm Type

Experimental

Arm Description

Arm Title

NBO group (6h)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Normobaric Hyperoxia (NBO)

Intervention Description

NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups

Intervention Type

Other

Intervention Name(s)

Low flow oxygen

Intervention Description

immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.

Primary Outcome Measure Information:

Title

Cerebral infarct volume

Description

The infarct volume is evaluated by MRI or CT scan

Time Frame

Within 72 hours after randomization

Secondary Outcome Measure Information:

Title

Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

Description

secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits)

Time Frame

24hours, 72hours, day7 after randomization

Title

The proportion of good prognosis

Description

the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death;with higher scores indicating more severe disability);The ratio of 0 to 2;

Time Frame

90 ± 10 days after randomization

Title

neurological function improvement rate

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);

Time Frame

Time Frame: 24 ± 6 hours

Title

modified Rankin Scale score (mRS) score

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

30 ± 7 days, 90 ± 10 days after randomization;

Title

Vascular recanalization rate

Description

Time Frame

Time Frame: 4 hours ± 15 minutes

Title

blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc

Description

Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:

Time Frame

24 ± 6 hours, 72 ± 24 hours

Title

Incidence of oxygen-related adverse events

Description

Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;

Time Frame

24 ± 6 hours,

Title

Incidence of 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 ± 6 hours;

Title

Incidence of 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

Incidence of any intracranial hemorrhage

Description

imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

Time Frame

24± 12 hours hours after randomization

Title

all-cause death rate

Description

clinical safety endpoint; Ratio of total deaths from all causes to all enrollments

Time Frame

90 ± 10 days after randomization

Title

Incidence of adverse events

Description

clinical safety endpoint;

Time Frame

90 ± 10 days after randomization

Title

Incidence of surgery-related complications

Description

clinical safety endpoint;

Time Frame

24± 12 hours hours after randomization

Title

stroke related death rate

Description

clinical safety endpoint; Stroke-related deaths as a proportion of all participants

Time Frame

90 ± 10 days after randomization;

Title

Vital signs:respiration(times/min)

Description

clinical safety endpoint;

Time Frame

0 hours, 2 hours, 4 hours after randomization;

Title

Vital signs:heart rate: (times/min)

Description

clinical safety endpoint;

Time Frame

0 hours, 2 hours, 4 hours after randomization;

Title

Vital signs:blood pressure(mmHg)

Description

clinical safety endpoint;

Time Frame

0 hours, 2 hours, 4 hours after randomization;

Title

Vital signs:oxygen saturation (%)

Description

clinical safety endpoint;

Time Frame

0 hours, 2 hours, 4 hours after randomization;

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Symptoms and signs were consistent with acute anterior circulation stroke, NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6; Met the indications for endovascular therapy; (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke The time from onset to randomization was within 24 hours; Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments); Patients and their families signed informed consent Exclusion Criteria: Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization; Seizures at stroke onset; Intracranial hemorrhage; Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal; Platelet count of less than 100,000 per cubic millimeter; Severe hepatic or renal dysfunction; Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 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; Life expectancy<90 days; Patients who could not complete the 90-day follow-up; Evidence of intracranial tumor; Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation; Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen. A history of severe allergies to contrast agents;

Central Contact Person:

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

Xunming Ji, MD

Phone

+86-10-83198952

jixm@ccmu.edu.cn

Facility Information:

Facility Name

Tianjin Huanhu Hospital

City

Tianjin

State/Province

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Wei, MD

Phone

15522349617

drweiming@163.com

12. IPD Sharing Statement

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Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

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