Normobaric Hyperoxia Stabilizing Ischemic Penumbra

NCT05781880 | Unknown DMC

• 1 other identifier: NBOTIP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

Normobaric Hyperoxia; Acute ischemic stroke; penumbra

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• penumbra volume at 4h following randomizing

  Day 0

• volume of core infarction at 4h following randomizing

  Day 0

• volume of hypoperfusion region hypoperfusion at 4h following randomizing

  Day 0

• National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing

  Day 1

• modified rankin scale (mRS) score at 90 days following randomizing

  Month 3

Study Arms (2)

NBO group

EXPERIMENTAL

Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask.

Other: Oxygen 100%

Control group

PLACEBO COMPARATOR

Control group will be given nasal oxygen (2L/min for 4h）. All other therapy measures are the same as experimental group.

Other: Oxygen 100%

Interventions

Oxygen 100% OTHER

NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)

Also known as: Normobaric hyperoxia

Control group; NBO group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Xunming Ji, MD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Qi, Ph.D

CONTACT

010-83199236; qizhifeng@xwh.ccmu.edu.cn

Shuhua Yuan, Ph.D

CONTACT

15538260193; 750495168@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes indexes will be assessed by trained neurologists or neuroradiologists who are blinded to the research content or patient grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 23, 2023
• Study Start: March 22, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (1)