Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128422
• Other study ID #: OPENS-1A
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: +86-10-83198952
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Endovascular Treatment
• Hyperoxia
• Ischemic Stroke
• Neuroprotection
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital of Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality	clinical safety endpoint;	90 ± 14 days after randomization
Secondary	Stroke recurrence	clinical safety endpoint;	90 ± 14 days,180 ± 30 days after randomization
Secondary	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
Secondary	Delta NIHSS	Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).	24 ± 12 hours after randomization
Secondary	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
Secondary	Cerebral infarct volume	Infarct volume is evaluated mainly through brain MRI(DWI) or CT	36 ± 12 hours after randomization