Normobaric Hyperoxia Stabilizing Ischemic Penumbra

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781880
• Other study ID #: NBOTIP
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Capital Medical University
• Contact: Zhifeng Qi, Ph.D
• Phone: 010-83199236
• Email: qizhifeng[@]xwh.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age=18?

• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Hyperoxia
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	penumbra volume at 4h following randomizing	the absolute penumbra volume comparison between NBO and control group	Day 0
Secondary	volume of core infarction at 4h following randomizing	core infarction volume comparison between NBO and control group	Day 0
Secondary	volume of hypoperfusion region hypoperfusion at 4h following randomizing	the volume of hypoperfusion region hypoperfusion comparison between NBO and control group	Day 0
Secondary	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
Secondary	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
Secondary	Barthel Index at 90 days following randomizing	the comparison of Barthel Index between NBO and control group	Month 3
Secondary	EQ-5D index at 90 days following randomizing	the comparison of EQ-5D index between NBO and control group	Month 3
Secondary	BBB injured biomarkers at baseline and 24h following randomizing	the levels of BBB injured biomarkers comparison between NBO and control group	Day 1
Secondary	Cerebral oxygen concentration at baseline and 4h following randomizing	the levels of cerebral oxygen comparison between NBO and control group	Day 0