Evidence map›Paper›PMID 33499916›Full record

ArticleTrials2021

Safety and efficacy of normobaric oxygenation on rescuing acute intracerebral hemorrhage-mediated brain damage-a protocol of randomized controlled trial.

Zhiying Chen, Jiayue Ding, Xiaoqin Wu, Bing Bao, Xianming Cao, Xiangbin Wu, Xiaoping Yin, Ran Meng

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04144868 (Normobaric Hyperoxia for Intracerebral Hemorrhage A Randomized Clinical Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04144868 phase2completednot on this map

Normobaric Hyperoxia for Intracerebral Hemorrhage A Randomized Clinical Trial

TypeinterventionalSponsorCapital Medical UniversityRan2020 to 2022Enrolled96ConditionsNormobaric Hyperoxia, Intracerebral HemorrhageArmsOxygen storage face masks and nasal catheter, Nasal catheter
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Endogenous zinc protoporphyrin formation critically contributes to hemorrhagic stroke-induced brain damage.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Zhiying ChenDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.
Jiayue DingDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.
Xiaoqin WuDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.
Bing BaoDepartment of Neurology, Affiliated Hospital of Jiujiang University, Jiujiang, 332000, Jiangxi, China.
Xianming CaoDepartment of Neurology, Affiliated Hospital of Jiujiang University, Jiujiang, 332000, Jiangxi, China.
Xiangbin WuDepartment of Neurology, Affiliated Hospital of Jiujiang University, Jiujiang, 332000, Jiangxi, China.
Xiaoping YinDepartment of Neurology, Affiliated Hospital of Jiujiang University, Jiujiang, 332000, Jiangxi, China. xiaopingbuxiao@126.com.
Ran MengDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China. victor65@126.com.
Jiujiang University · CNCapital Medical University · CNChinese Institute for Brain Research · CN

Funding

National Key Clinical Specialty Discipline Construction Program of China 2017YFC1308401National Key Clinical Specialty Discipline Construction Program of China 2018FY100903National Natural Science Foundation of China 81660209National Natural Science Foundation of China 81760221National Natural Science Foundation of China 81960221
6 · The paper itself

Abstract

backgroundAll of the existing medication and surgical therapies currently cannot completely inhibit intracerebral hemorrhage (ICH)-mediated brain damage, resulting in disability in different degrees in the involved patients. Normobaric oxygenation (NBO) was reported attenuating ischemic brain injury. Herein, we aimed to explore the safety and efficacy of NBO on rescuing the damaged brain tissues secondary to acute ICH, especially those in the perihematoma area being threatened by ischemia and hypoxia.

methodsA total of 150 patients confirmed as acute spontaneous ICH by computed tomography (CT) within 6 h after symptoms onset, will enroll in this study after signing the informed consent, and enter into the NBO group or control group randomly according to a random number. In the NBO group, patients will inhale high-flow oxygen (8 L/min, 1 h each time for 6 cycles daily) and intake low-flow oxygen (2 L/min) in intermittent periods by mask for a total of 7 days. While in the control group, patients will breathe in only low-flow oxygen (2 L/min) by mask for 7 consecutive days. Computed tomography and perfusion (CT/CTP) will be used to evaluate cerebral perfusion status and brain edema. CT and CTP maps in the two groups at baseline and day 7 and 14 after NBO or low-flow oxygen control will be compared. The primary endpoint is mRS at both Day14 post-ICH and the end of the 3rd month follow-up. The secondary endpoints include NIHSS and plasma biomarkers at baseline and Day-1, 7, and 14 after treatment, as well as the NIHSS at the end of the 3rd month post-ICH and the incidence of bleeding recurrence and the mortalities within 3 months post-ICH. DISCUSSION: This study will provide preliminary clinical evidence about the safety and efficacy of NBO on correcting acute ICH and explore some mechanisms accordingly, to offer reference for larger clinical trials in the future.

trial registrationClinicalTrials.gov NCT04144868 . Retrospectively registered on October 29, 2019.

Indexed as

AdolescentAdultAgedAged, 80 and overBrain EdemaBrain InjuriesCerebral CortexCerebral HemorrhageFemaleFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMasksMiddle AgedOxygenOxygenCerebral perfusionIntracerebral hemorrhageNormobaric hyperoxiaRandomized controlled trial

Identifiers

PMID33499916
PMCPMC7836205
OpenAlexW3124213350

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.