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N/A N=49 Randomized Single-blind Treatment

The Efficacy of Normobaric Oxygen on Chronic Cerebral Ischemia

Normobaric Oxygen · Cerebral Ischemia

Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: The Fronto-central Theta Absolute Power Change Rate — 0.14; -0.12 ratio

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
normobaric oxygen (Device); room air (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Capital Medical University
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
The Fronto-central Theta Absolute Power Change Rate
0.14; -0.12
PRIMARY
The Fronto-central Delta Absolute Power Reduction Rate
0.21; -0.01
SECONDARY
The Post-intervention Fronto-central Theta/Alpha Ratio
0.36; 0.35
SECONDARY
The Post-intervention Fronto-central (Delta+Theta)/(Alpha+Beta) Ratio
0.64; 0.58
SECONDARY
The Post-intervention Fronto-central Delta/Alpha Ratio
0.33; 0.35
SECONDARY
The Fronto-central Wavelet Entropy Change
-0.15; -0.01

Summary

Chronic cerebral ischemia (CCI) is viewed as an alarming state induced by long-term reduction in cerebral perfusion, which is associated with neurological deficits and high risk of stroke occurrence or recurrence. CCI accounts for a large proportion in both outpatient and inpatient subjects with cerebrovascular disease, while the treatment of CCI remains a formidable challenge to clinicians. Normobaric oxygen (NBO) is an adjuvant hyper-oxygenation intervention supplied with one atmosphere pressure (1ATA=101.325kPa). A plethora of studies have demonstrated the efficacy of NBO on the penumbra in acute stroke. NBO has been shown to increase oxygen pressure, raise intracranial blood flow, protect blood-brain barrier and enhance neuro-protective effects. As the similar underlying mechanisms shared by the penumbra in stroke and the ischemic-hypoxic brain tissues in CCI, the investigators speculate that NBO may serve as a promising therapeutic strategy for attenuating short-term symptoms or improving long-term clinical outcomes amongst patients with CCI. Due to the scant research exploring the efficacy of NBO for treating CCI so far, the clinical studies are warranted to verify this hypothesis urgently.

Eligibility Criteria

Inclusion criteria: (1) age from 18 to 80 years; (2) diagnosis of intracranial arterial stenosis or internal carotid arterial stenosis; (3) NIHSS≤4 and mRS≤2; (4) signed informed consent. Exclusion criteria: (1) brain infarction occurring within recent two months; (2) intracranial arterial aneurysm, dissection or malformation; (3) history of cerebral hemorrhage or subarachnoid hemorrhage; (4) history of cerebral trauma; (5) history of other brain injury or disorders; (6) austere diseases such as cancer, heart failure, respiratory failures; (7) respiratory diseases; (8) poor compliance.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03745092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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