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The Efficacy of Normobaric Oxygen on Chronic Cerebral Ischemia

NCT03745092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-04-08

Study results available
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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.

Conditions

  • Normobaric Oxygen
  • Cerebral Ischemia

Interventions

DEVICE

normobaric oxygen

Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).

DEVICE

room air

The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-12-31
Completion
2020-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745092 on ClinicalTrials.gov