Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

NCT03620370 | Completed

• 1 other identifier: OPENS-1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.

Conditions

Stroke, Acute

Keywords

Normobaric hyperoxia;; Acute ischemic stroke;; vascular recanalization;; Endovascular treatment;; reperfusion therapy

Outcome Measures

Primary Outcomes (1)

• Cerebral infarct volume

  Infarct volume is evaluated mainly through brain MRI(DWI)

  24-48h after randomization

Secondary Outcomes (16)

• levels of blood biomarkers

  baseline; 24 ± 6 hours, 7 ± 2 days

• modified Rankin Scale score (mRS)

  30 ± 5 days, 90 ± 10 days after randomization

• The good prognosis at 90 days assessed by modified Rankin scale (mRS).

  90 ± 10 days after randomization

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

  2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]

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

  from baseline to 24 ± 6 hours

Other Outcomes (1)

• Subgroup analysis of infarct volume

  24-48h after randomization

Study Arms (2)

NBO group

EXPERIMENTAL

Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.

Drug: Normobaric oxygen therapy

Control group

NO INTERVENTION

The participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

Interventions

Normobaric oxygen therapy DRUG

In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.

NBO group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age≥18 and ≤ 80;
• Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
• Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
• Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
• NIHSS score≥6分
• Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
• Informed consent obtained;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu hospital;Capital Medical University

Beijin, China

Location

Related Publications (2)

• Niu H, Ding J, Chen Z, Yuan S, Qi Z, Ji X, Li W. Normobaric Hyperoxia in Patients With Acute Stroke: Enhancing Neuroprotection Through Inhibition of Inflammation. J Am Heart Assoc. 2025 Oct 9:e041825. doi: 10.1161/JAHA.125.041825. Online ahead of print.

  PMID: 41065265 DERIVED

• Li W, Qi Z, Ma Q, Ding J, Wu C, Song H, Yang Q, Duan J, Liu L, Kang H, Wu L, Ji K, Zhao W, Li C, Sun C, Li N, Fisher M, Ji X, Liu KJ. Normobaric Hyperoxia Combined With Endovascular Treatment for Patients With Acute Ischemic Stroke: A Randomized Controlled Clinical Trial. Neurology. 2022 Aug 23;99(8):e824-e834. doi: 10.1212/WNL.0000000000200775. Epub 2022 Jun 17.

  PMID: 35715198 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 12, 2018
• Primary Completion: July 21, 2019
• Study Completion: October 19, 2019
• Last Updated: July 19, 2023

Record last verified: 2020-07

Locations

CN (1)