Normobaric HyperoxiaPhase 2NCT04144868

Normobaric Hyperoxia for Intracerebral Hemorrhage

A Phase 2 study testing Oxygen storage face masks and nasal catheter and Nasal catheter in people with Normobaric Hyperoxia and Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Normobaric Hyperoxia, Intracerebral Hemorrhage
What is being tested?: Oxygen storage face masks and nasal catheter and Nasal catheter
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteChina
Study dates: 15 Jan 2020to 31 Jan 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

supratentorial hematomas confirmed by admitted cranial computed tomography (CT), with the volume ranging from 10 to 30 mL;
age 18-80 years;
National Institute of Health Stroke Scale (NIHSS) ≥ 6 and Glasgow Coma Scale (GCS) > 8 at admission;
onset-to-enrollment time ≤ 24 h;
signed informed consent.

Who cannot join

a history of ICH, ischemic attack, brain tumor, brain trauma, and other intracranial injury or disorders;
pre-stroke modified ranking scales (mRS) ≥ 1;
life-threatening condition;
pre-stroke complicated with austere diseases such as cancer, heart failure, and respiratory failures;
severe liver and kidney disorders;
a history of respiratory diseases;
poor compliance;
participation in other clinical trials within the previous three months.

Trial locations and contacts

1 site in 1 country.

China1 site

Xuanwu Hospital, Captial Medical University
Beijing, 100053

Other trials in China

About this study

Official title: Normobaric Hyperoxia for Intracerebral Hemorrhage A Randomized Clinical Trial

Perihematoma edema (PHE), as the major injury for intracranial hemorrhage (ICH) involves more than the initial tissue damage induced directly by the hematoma. How to improve hypoxia in perihematoma seems to be a promising therapeutic candidate paradigm for ICH due to its pivotal role in the pathogenesis of perihematomas. Normobaric hyperoxia (NBO), supplied by a face mask (such as oxygen storage face mask) with atmosphere pressure (1ATA = 101.325 kPa, 100% O2), has been considered a safe, convenient, and promising therapy for correcting various diseases and thus garnered great attention in recent years. The previous study identified that early NBO could attenuate blood-brain barrier damage, rescue penumbra and finally improve the prognosis of ischemic stroke in patients with delayed rt-PA treatment. Therefore, given the profound effectiveness in the ischemic penumbra, we hypothesized that NBO might yield additional benefits for the ischemic-hypoxic tissues surrounding the hematoma in patients with ICH. Although many clinical trials have shown the effectiveness and safety of NBO in treating ischemic stroke, there is currently a lack of trials focusing on using NBO to treat ICH. Accordingly, we conducted a proof-of-concept, single-center, randomized controlled trial to evaluate the safety and efficacy of NBO in treating ICH patients so as to explore an innovative adjuvant therapy for ICH.

Read the detailed description

Intracerebral hemorrhage (ICH) is an intractable and life-threatening stroke subtype that imposes a significant impact on people's well-being and quality of life. ICH-induced mechanical compression to the surrounding brain tissue is a major injury that increases intracranial pressure (ICP). High ICP can decrease cerebral blood flow (CBF) and influence cerebral metabolism in perihematoma and even the whole brain. Decreased aerobic metabolism and perfusion in perihematomal injury can exacerbate edema and enlarge hematoma. Moreover, secondary injury in the perihematoma, such as ischemia, oxidative stress, inflammatory response, and protease release, involves more than the initial tissue damage induced directly by the hematoma. Theoretically, low CBF and abnormal metabolism in ICH patients expose the brain tissue to the ischemic-hypoxic condition, which is similar to that in the ischemic penumbra in stroke. Therefore, the key to treating ICH is to find an approach that can rescue the perihematoma. Improving hypoxia in perihematoma seems to be a promising therapeutic candidate paradigm for ICH due to its pivotal role in the pathogenesis of perihematomas.

Normobaric hyperoxia (NBO), supplied by a face mask (such as oxygen storage face mask) with atmosphere pressure (1ATA = 101.325 kPa, 100% O2), has been considered a safe, convenient, and promising therapy for correcting various diseases and thus garnered great attention in recent years. The effectiveness of NBO on ischemic stroke (IS) has been fully identified. A plethora of studies show that NBO is capable of increasing the partial pressure of oxygen (PO2), elevating the blood flow and volume, protecting the blood-brain barrier (BBB), improving oxidative metabolism, reducing free radical damage, and even relieving inflammatory response in the penumbra. Rapid amelioration of hypoxia in brain tissue can restore brain dysfunction and improve clinical prognoses. Likewise, NBO is also regarded as a promising method for treating ICH. An animal study found that NBO for a period of 6 h per day for 3 consecutive days imposed a remarkable neuroprotective effect in rat ICH, improved neurological function, reduced brain edema, downregulated HIF-1α and VEGF expression and showed a reduction in apoptotic cells in the perihematoma. Although many clinical trials have shown the effectiveness and safety of NBO in treating ischemic stroke, there is currently a lack of trials focusing on using NBO to treat ICH. Accordingly, we conducted a proof-of-concept, single-center, randomized controlled trial to evaluate the safety and efficacy of NBO in treating ICH patients so as to explore an innovative adjuvant therapy for ICH.

Conditions: Normobaric Hyperoxia, Intracerebral Hemorrhage
Being tested: Oxygen storage face masks and nasal catheter, Nasal catheter
Keywords: Intracerebral Hemorrhage, Normobaric Hyperoxia, Perihematomal Edema
Medical subject headings: Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxygen storage face masks and nasal catheterDevice
Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Nasal catheterDevice
Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.

Study groups in NCT04144868
Study group	Role	What they receive
NBO group	Experimental	Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission. Receives: Device: Oxygen storage face masks and nasal catheter
Control group	Placebo comparator	Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days. Receives: Device: Nasal catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With mRS 0-3
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days

Secondary outcomes (17)

NIHSS Scores
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Measured: 3 days
NIHSS Scores
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Measured: 7 days
NIHSS Scores
The NIHSS is commonly used to evaluate neurological deficits in stroke and comprises five items in 11 fields of different neurological statuses (scores range from 0-42, representing normal to severe neurological deficits).
Measured: 14 days
Glasgow Coma Scale
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Measured: 3 days
Glasgow Coma Scale
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Measured: 7 days
Glasgow Coma Scale
Glasgow Coma Scale is a practical method for the evaluation of impairment of conscious level in response to defined stimuli, which contains three parts, including eye-opening, verbal response, and motor response (scores range from 3-15, representing deep coma to normal).
Measured: 14 days
Barthel Index
Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Measured: 90 days
mRS Distribution
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days
Hematoma Volume
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 3 days
Hematoma Volume
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 7 days
Hematoma Volume
Hematoma volume in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 14 days
Absolute Perihematomal Edema Volume
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 3 days
Absolute Perihematomal Edema Volume
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 7 days
Absolute Perihematomal Edema Volume
Absolute perihematomal edema in cranial CT scan, calculated by the software from United Imaging (United Imaging Healthcare Co., Ltd., Shanghai, China).
Measured: 14 days
Relative Perihematomal Edema Volume
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Measured: 3 days
Relative Perihematomal Edema Volume
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Measured: 7 days
Relative Perihematomal Edema Volume
The relative perihematomal edema was calculated by dividing the absolute perihematomal edema volume by the baseline hematoma volume to obtain a dimensionless ratio.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202031 Jan 2022

First posted30 Oct 2019
Study start15 Jan 2020
Primary completion31 Dec 2021
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Normobaric HyperoxiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) or not (2 L/min via nasal catheter for 7 days) at admission.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04144868
Sponsor's protocol ID: NOTCH
Status last verified: Apr 2025
First submitted: 22 Oct 2019
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

McCourt R, Gould B, Kate M, Asdaghi N, Kosior JC, Coutts S, Hill MD, Demchuk A, Jeerakathil T, Emery D, Butcher KS. Blood-brain barrier compromise does not predict perihematoma edema growth in intracerebral hemorrhage. Stroke. 2015 Apr;46(4):954-60. doi: 10.1161/STROKEAHA.114.007544. Epub 2015 Feb 19.
PubMed 25700288
Ding J, Zhou D, Sui M, Meng R, Chandra A, Han J, Ding Y, Ji X. The effect of normobaric oxygen in patients with acute stroke: a systematic review and meta-analysis. Neurol Res. 2018 Jun;40(6):433-444. doi: 10.1080/01616412.2018.1454091. Epub 2018 Mar 30.
PubMed 29600891
Cai L, Stevenson J, Geng X, Peng C, Ji X, Xin R, Rastogi R, Sy C, Rafols JA, Ding Y. Combining Normobaric Oxygen with Ethanol or Hypothermia Prevents Brain Damage from Thromboembolic Stroke via PKC-Akt-NOX Modulation. Mol Neurobiol. 2017 Mar;54(2):1263-1277. doi: 10.1007/s12035-016-9695-7. Epub 2016 Jan 28.
PubMed 26820681
Xu Q, Fan SB, Wan YL, Liu XL, Wang L. The potential long-term neurological improvement of early hyperbaric oxygen therapy on hemorrhagic stroke in the diabetics. Diabetes Res Clin Pract. 2018 Apr;138:75-80. doi: 10.1016/j.diabres.2018.01.017. Epub 2018 Feb 3.
PubMed 29408705
Shi SH, Qi ZF, Luo YM, Ji XM, Liu KJ. Normobaric oxygen treatment in acute ischemic stroke: a clinical perspective. Med Gas Res. 2016 Oct 14;6(3):147-153. doi: 10.4103/2045-9912.191360. eCollection 2016 Jul-Sep.
PubMed 27867482
Liang J, Qi Z, Liu W, Wang P, Shi W, Dong W, Ji X, Luo Y, Liu KJ. Normobaric hyperoxia slows blood-brain barrier damage and expands the therapeutic time window for tissue-type plasminogen activator treatment in cerebral ischemia. Stroke. 2015 May;46(5):1344-1351. doi: 10.1161/STROKEAHA.114.008599. Epub 2015 Mar 24.
PubMed 25804925
Fujiwara N, Mandeville ET, Geng X, Luo Y, Arai K, Wang X, Ji X, Singhal AB, Lo EH. Effect of normobaric oxygen therapy in a rat model of intracerebral hemorrhage. Stroke. 2011 May;42(5):1469-72. doi: 10.1161/STROKEAHA.110.593350. Epub 2011 Mar 17.
PubMed 21415401
You P, Lin M, Li K, Ye X, Zheng J. Normobaric oxygen therapy inhibits HIF-1alpha and VEGF expression in perihematoma and reduces neurological function defects. Neuroreport. 2016 Mar 23;27(5):329-36. doi: 10.1097/WNR.0000000000000542.
PubMed 26872098
Xu H, Li R, Duan Y, Wang J, Liu S, Zhang Y, He W, Qin X, Cao G, Yang Y, Zhuge Q, Yang J, Chen W. Quantitative assessment on blood-brain barrier permeability of acute spontaneous intracerebral hemorrhage in basal ganglia: a CT perfusion study. Neuroradiology. 2017 Jul;59(7):677-684. doi: 10.1007/s00234-017-1852-9. Epub 2017 Jun 3.
PubMed 28580533
Chen Z, Ding J, Bao B, Wu M, Cao X, Li W, Wu X, Xia Z, Xiang Y, Chen L, Liu H, Ji X, Yin X, Meng R. Normobaric hyperoxia for intracerebral hemorrhage: a randomized clinical trial. BMC Med. 2025 Dec 7;24(1):21. doi: 10.1186/s12916-025-04565-2.
PubMed 41353144
Chen Z, Ding J, Wu X, Bao B, Cao X, Wu X, Yin X, Meng R. Safety and efficacy of normobaric oxygenation on rescuing acute intracerebral hemorrhage-mediated brain damage-a protocol of randomized controlled trial. Trials. 2021 Jan 26;22(1):93. doi: 10.1186/s13063-021-05048-4.
PubMed 33499916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Not yet recruitingPhase 3
Normobaric Hyperoxia With Extended-Window Endovascular Therapy for Acute Ischemic Stroke (OPENS-EXTEND)
Stroke, Acute, Neuroprotection
RecruitingPhase 2
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Traumatic Spinal Cord Injuries
RecruitingPhase 3
Normobaric Oxygen in AIS Transferred for EVT
Ischemic Stroke
Not yet recruitingPhase 3
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Stroke Acute

All Normobaric Hyperoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Normobaric Hyperoxia for Intracerebral Hemorrhage A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04144868
Acronym / sponsor ID: NOTCH
Conditions: Normobaric Hyperoxia, Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage, Normobaric Hyperoxia, Perihematomal Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Capital Medical UniversityUniversity, hospital or other
Collaborators: Jiujiang University Affiliated Hospital
Study start: 15 Jan 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 30 Oct 2019 (actual)
Results: Posted 30 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) or not (2 L/min via nasal catheter for 7 days) at admission.

Arm	Type	Receives
NBO group	Experimental	Device: Oxygen storage face masks and nasal catheterGiving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.
Control group	Placebo comparator	Device: Nasal catheterGiving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

supratentorial hematomas confirmed by admitted cranial computed tomography (CT), with the volume ranging from 10 to 30 mL;
age 18-80 years;
National Institute of Health Stroke Scale (NIHSS) ≥ 6 and Glasgow Coma Scale (GCS) > 8 at admission;
onset-to-enrollment time ≤ 24 h;
signed informed consent.

Key exclusion criteria (8 listed)

a history of ICH, ischemic attack, brain tumor, brain trauma, and other intracranial injury or disorders;
pre-stroke modified ranking scales (mRS) ≥ 1;
life-threatening condition;
pre-stroke complicated with austere diseases such as cancer, heart failure, and respiratory failures;
severe liver and kidney disorders;

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 storage face masks and nasal catheterGiving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission.	Device	NBO group
Nasal catheterGiving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days.	Device	Control group

Primary outcome

Percentage of Patients With mRS 0-3
Time frame: 90 days
modified Rankin Scale (mRS), an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death)

17 secondary outcomes

NIHSS Scores
Time frame: 3 days
NIHSS Scores
Time frame: 7 days
NIHSS Scores
Time frame: 14 days
Glasgow Coma Scale
Time frame: 3 days
Glasgow Coma Scale
Time frame: 7 days
Glasgow Coma Scale
Time frame: 14 days
Barthel Index
Time frame: 90 days
mRS Distribution
Time frame: 90 days
Hematoma Volume
Time frame: 3 days
Hematoma Volume
Time frame: 7 days
Hematoma Volume
Time frame: 14 days
Absolute Perihematomal Edema Volume
Time frame: 3 days
Absolute Perihematomal Edema Volume
Time frame: 7 days
Absolute Perihematomal Edema Volume
Time frame: 14 days
Relative Perihematomal Edema Volume
Time frame: 3 days
Relative Perihematomal Edema Volume
Time frame: 7 days
Relative Perihematomal Edema Volume
Time frame: 14 days

Results and safety

Results posted to the registry on 30 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NBO Group	48	48
Control Group	48	48

Primary outcome: Percentage of Patients With mRS 0-3

Time frame: 90 days. Count of participants. Unit: Participants

Measure	NBO Group n = 48	Control Group n = 48
Value	39	27

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization to 90 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NBO Group	0 of 48 (0%)	12 of 48 (25%)	0 of 48
Control Group	0 of 48 (0%)	12 of 48 (25%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25700288McCourt R, Gould B, Kate M, Asdaghi N, Kosior JC, Coutts S, Hill MD, Demchuk A, Jeerakathil T, Emery D, Butcher KS. Blood-brain barrier compromise does not predict perihematoma edema growth in intracerebral hemorrhage. Stroke. 2015 Apr;46(4):954-60. doi: 10.1161/STROKEAHA.114.007544. Epub 2015 Feb 19.
Background: PubMed 29600891Ding J, Zhou D, Sui M, Meng R, Chandra A, Han J, Ding Y, Ji X. The effect of normobaric oxygen in patients with acute stroke: a systematic review and meta-analysis. Neurol Res. 2018 Jun;40(6):433-444. doi: 10.1080/01616412.2018.1454091. Epub 2018 Mar 30.
Background: PubMed 26820681Cai L, Stevenson J, Geng X, Peng C, Ji X, Xin R, Rastogi R, Sy C, Rafols JA, Ding Y. Combining Normobaric Oxygen with Ethanol or Hypothermia Prevents Brain Damage from Thromboembolic Stroke via PKC-Akt-NOX Modulation. Mol Neurobiol. 2017 Mar;54(2):1263-1277. doi: 10.1007/s12035-016-9695-7. Epub 2016 Jan 28.
Background: PubMed 29408705Xu Q, Fan SB, Wan YL, Liu XL, Wang L. The potential long-term neurological improvement of early hyperbaric oxygen therapy on hemorrhagic stroke in the diabetics. Diabetes Res Clin Pract. 2018 Apr;138:75-80. doi: 10.1016/j.diabres.2018.01.017. Epub 2018 Feb 3.
Background: PubMed 27867482Shi SH, Qi ZF, Luo YM, Ji XM, Liu KJ. Normobaric oxygen treatment in acute ischemic stroke: a clinical perspective. Med Gas Res. 2016 Oct 14;6(3):147-153. doi: 10.4103/2045-9912.191360. eCollection 2016 Jul-Sep.
Background: PubMed 25804925Liang J, Qi Z, Liu W, Wang P, Shi W, Dong W, Ji X, Luo Y, Liu KJ. Normobaric hyperoxia slows blood-brain barrier damage and expands the therapeutic time window for tissue-type plasminogen activator treatment in cerebral ischemia. Stroke. 2015 May;46(5):1344-1351. doi: 10.1161/STROKEAHA.114.008599. Epub 2015 Mar 24.
Background: PubMed 21415401Fujiwara N, Mandeville ET, Geng X, Luo Y, Arai K, Wang X, Ji X, Singhal AB, Lo EH. Effect of normobaric oxygen therapy in a rat model of intracerebral hemorrhage. Stroke. 2011 May;42(5):1469-72. doi: 10.1161/STROKEAHA.110.593350. Epub 2011 Mar 17.
Background: PubMed 26872098You P, Lin M, Li K, Ye X, Zheng J. Normobaric oxygen therapy inhibits HIF-1alpha and VEGF expression in perihematoma and reduces neurological function defects. Neuroreport. 2016 Mar 23;27(5):329-36. doi: 10.1097/WNR.0000000000000542.
Results publication: PubMed 28580533Xu H, Li R, Duan Y, Wang J, Liu S, Zhang Y, He W, Qin X, Cao G, Yang Y, Zhuge Q, Yang J, Chen W. Quantitative assessment on blood-brain barrier permeability of acute spontaneous intracerebral hemorrhage in basal ganglia: a CT perfusion study. Neuroradiology. 2017 Jul;59(7):677-684. doi: 10.1007/s00234-017-1852-9. Epub 2017 Jun 3.
Derived from this study: PubMed 41353144Chen Z, Ding J, Bao B, Wu M, Cao X, Li W, Wu X, Xia Z, Xiang Y, Chen L, Liu H, Ji X, Yin X, Meng R. Normobaric hyperoxia for intracerebral hemorrhage: a randomized clinical trial. BMC Med. 2025 Dec 7;24(1):21. doi: 10.1186/s12916-025-04565-2.
Derived from this study: PubMed 33499916Chen Z, Ding J, Wu X, Bao B, Cao X, Wu X, Yin X, Meng R. Safety and efficacy of normobaric oxygenation on rescuing acute intracerebral hemorrhage-mediated brain damage-a protocol of randomized controlled trial. Trials. 2021 Jan 26;22(1):93. doi: 10.1186/s13063-021-05048-4.
Individual participant dataSharing planned: No

Related trials for Normobaric Hyperoxia

Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Not yet recruitingPhase 3
Normobaric Hyperoxia With Extended-Window Endovascular Therapy for Acute Ischemic Stroke (OPENS-EXTEND)
Stroke, Acute, Neuroprotection
RecruitingPhase 2
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Traumatic Spinal Cord Injuries
RecruitingPhase 3
Normobaric Oxygen in AIS Transferred for EVT
Ischemic Stroke
Not yet recruitingPhase 3
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Stroke Acute

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 30 Apr 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With mRS 0-3 (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04144868, which also lists 11 linked publications.

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 30 Apr 2025.