Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Endovascular Treatment; Stroke; Neuroprotection
• Interventions: Other: Normobaric oxygen therapy

• Registration Number: NCT05128422
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Status Verified: 2023-10
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBO+EVT group	Normobaric oxygen therapy	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.

Primary Outcome Measures

Name	Time	Method
Early neurologic improvement (ENI) at 24 hours	24 ± 12 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

Name	Time	Method
Mortality	90 ± 14 days after randomization	clinical safety endpoint;
modified Rankin Scale score (mRS)	90 ± 14 days after randomization	secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)
Revascularization on 24-hour follow-up imaging	24 ± 12 hours hours after randomization	secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3
Early neurologic deterioration	24 ± 12 hours after randomization	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;
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours	24 ± 12 hours after randomization	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)
Symptomatic Intracerebral Hemorrhage	24± 12 hours hours after randomization	imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Stroke recurrence	90 ± 14 days，180 ± 30 days after randomization	clinical safety endpoint;
Cerebral infarct volume	36 ± 12 hours after randomization	Infarct volume is evaluated mainly through brain MRI(DWI) or CT
The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score	90 ± 14 days after randomization	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	24 ± 12 hours after randomization	Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).
National Institutes of Health Stroke Scale(NIHSS) Score	4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization	the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits
Barthel Index (BI)	90 ± 14 days after randomization	secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Percent change NIHSS	24 ± 12 hours after randomization	Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\]

Trial Locations

Locations (1)

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, China