Normobaric Hyperoxia Stabilizing Ischemic Penumbra

Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke

To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Oxygen 100%

Detailed Description

All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhifeng Qi, Ph.D; Phone Number: 010-83199236; Email: qizhifeng@xwh.ccmu.edu.cn
• Study Contact Backup: Name: Shuhua Yuan, Ph.D; Phone Number: 15538260193; Email: 750495168@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Xuanwu Hospital of Capital Medical University
      • Contact: Shuhua Yuan, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age≥18岁
• The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score：6-20
• Level of consciousness on admission：0-1
• mRS score before stroke: 0-1
• Patients who did not receive revascularization therapy
• The time from onset (finally normal) to randomization is less than 24h
• Patients who signed informed consent
• CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery
• The low-perfusion area with Tmax>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8.

Exclusion Criteria:

• Evidence of rapid improvement in neurological function and NIHSS score <6, or spontaneous recanalization before randomization
• The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease)
• Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal)
• Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected
• Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing
• It is necessary to inhale (>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2>95%)
• Anemia or polycythemia vera or other conditions needing emergency oxygen patients
• Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask
• Baseline blood glucose <2.78mmol/L or >22.2mmol/L
• Baseline platelet count <50×109/L
• Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR>3 or PPT more than 3 times
• Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min)
• Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg
• Acute myocardial infarction suspected
• Pregnancy,
• Life expectancy <90 days
• Heart, liver and kidney failure
• Magnetic resonance contraindications
• Claustrophobia
• Allergic to contrast media
• Participating in other drug or device research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBO group; Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask.	Other: Oxygen 100%; NBO therapy were given 100% oxygen via a face mask (10L/min for 4h); Other Names: Normobaric hyperoxia
Placebo Comparator: Control group; Control group will be given nasal oxygen (2L/min for 4h）. All other therapy measures are the same as experimental group.	Other: Oxygen 100%; NBO therapy were given 100% oxygen via a face mask (10L/min for 4h); Other Names: Normobaric hyperoxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changing of penumbra volume from baseline	the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
penumbra volume at 4h following randomizing	the absolute penumbra volume comparison between NBO and control group	Day 0
volume of core infarction at 4h following randomizing	core infarction volume comparison between NBO and control group	Day 0
volume of hypoperfusion region hypoperfusion at 4h following randomizing	the volume of hypoperfusion region hypoperfusion comparison between NBO and control group	Day 0
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing	the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome.	Day 1
modified rankin scale (mRS) score at 90 days following randomizing	the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome.	Month 3
Barthel Index at 90 days following randomizing	the comparison of Barthel Index between NBO and control group	Month 3
EQ-5D index at 90 days following randomizing	the comparison of EQ-5D index between NBO and control group	Month 3
BBB injured biomarkers at baseline and 24h following randomizing	the levels of BBB injured biomarkers comparison between NBO and control group	Day 1
Cerebral oxygen concentration at baseline and 4h following randomizing	the levels of cerebral oxygen comparison between NBO and control group	Day 0

Collaborators and Investigators

• Sponsor: Ji Xunming,MD,PhD
• Investigators: Principal Investigator: Xunming Ji, MD, Xuanwu Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; penumbra; Normobaric Hyperoxia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Stroke; Ischemic Stroke; Ischemia; Hyperoxia
• Other Study ID Numbers: NBOTIP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No