The Efficacy of Normobaric Oxygen on Chronic Cerebral Ischemia

NCT03745092 | Completed Results

• 1 other identifier: NBO-CCI
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

normobaric oxygen; cerebral ischemia; EEG

Outcome Measures

Primary Outcomes (2)

• The Fronto-central Theta Absolute Power Change Rate

  The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central theta absolute power change rate was calculated as the theta (4-8Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the theta frequency band.

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

• The Fronto-central Delta Absolute Power Reduction Rate

  The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central delta absolute power change rate was calculated as the delta (1-4Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The delta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the delta frequency band.

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

Secondary Outcomes (4)

• The Post-intervention Fronto-central Theta/Alpha Ratio

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

• The Post-intervention Fronto-central (Delta+Theta)/(Alpha+Beta) Ratio

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

• The Post-intervention Fronto-central Delta/Alpha Ratio

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

• The Fronto-central Wavelet Entropy Change

  30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG

Study Arms (2)

NBO group

EXPERIMENTAL

Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min.

Device: normobaric oxygen

Control group

PLACEBO COMPARATOR

Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min.

Device: room air

Interventions

normobaric oxygen DEVICE

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

NBO group

room air DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Captial Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Pro. Ran Meng
• Organization: Xuanwu Hospital, Capital Medical University

ranmeng2011@pku.org.cn

+86-10-83199280

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 19, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: April 8, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

CN (1)