Acute Ischemic StrokeNCT05781880
Normobaric Hyperoxia Stabilizing Ischemic Penumbra
A study testing Oxygen 100% in people with Acute Ischemic Stroke, run by Ji Xunming,MD,PhD at 1 site in China.
Trial summary
To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Oxygen 100%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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%)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100032
Shuhua Yuan, Ph.D
About this study
Official title: 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.
Read the 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) .
- Conditions
- Acute Ischemic Stroke
- Being tested
- Oxygen 100%
- Keywords
- Normobaric Hyperoxia, Acute ischemic stroke, penumbra
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen 100%Other
Also called Normobaric hyperoxia
NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)
| Study group | Role | What they receive |
|---|---|---|
| NBO group | Experimental | Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask. Receives: 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. Receives: Other: Oxygen 100% |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing of penumbra volume from baseline
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
Measured: Day 0
Secondary outcomes (9)
penumbra volume at 4h following randomizing
the absolute penumbra volume comparison between NBO and control group
Measured: Day 0
volume of core infarction at 4h following randomizing
core infarction volume comparison between NBO and control group
Measured: Day 0
volume of hypoperfusion region hypoperfusion at 4h following randomizing
the volume of hypoperfusion region hypoperfusion comparison between NBO and control group
Measured: 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.
Measured: 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.
Measured: Month 3
Barthel Index at 90 days following randomizing
the comparison of Barthel Index between NBO and control group
Measured: Month 3
EQ-5D index at 90 days following randomizing
the comparison of EQ-5D index between NBO and control group
Measured: Month 3
BBB injured biomarkers at baseline and 24h following randomizing
the levels of BBB injured biomarkers comparison between NBO and control group
Measured: Day 1
Cerebral oxygen concentration at baseline and 4h following randomizing
the levels of cerebral oxygen comparison between NBO and control group
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start22 Mar 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD, Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781880
- Sponsor's protocol ID
- NBOTIP
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05781880
- Acronym / sponsor ID
- NBOTIP
- Conditions
- Acute Ischemic Stroke
- Keywords
- Normobaric Hyperoxia, Acute ischemic stroke, penumbra
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBO group | Experimental | Other: Oxygen 100%Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask. |
| Control group | Placebo comparator | Other: Oxygen 100%Control group will be given nasal oxygen (2L/min for 4h）. All other therapy measures are the same as experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen 100%Also: Normobaric hyperoxiaNBO therapy were given 100% oxygen via a face mask (10L/min for 4h) | Other | Control group, NBO group |
Primary outcome
changing of penumbra volume from baseline
Time frame: Day 0
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
9 secondary outcomes
penumbra volume at 4h following randomizing
Time frame: Day 0
volume of core infarction at 4h following randomizing
Time frame: Day 0
volume of hypoperfusion region hypoperfusion at 4h following randomizing
Time frame: Day 0
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing
Time frame: Day 1
modified rankin scale (mRS) score at 90 days following randomizing
Time frame: Month 3
Barthel Index at 90 days following randomizing
Time frame: Month 3
EQ-5D index at 90 days following randomizing
Time frame: Month 3
BBB injured biomarkers at baseline and 24h following randomizing
Time frame: Day 1
Cerebral oxygen concentration at baseline and 4h following randomizing
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen 100% in people with Acute Ischemic Stroke, run by Ji Xunming,MD,PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhifeng Qi, Ph.D (010-83199236, qizhifeng@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changing of penumbra volume from baseline (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.