Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-03-31

Brief Summary

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Animal studies have shown that preconditioning with hyperbaric oxygen can induce central nervous system and heart ischemic tolerance. This study was designed to determine the protective effect of hyperbaric oxygen preconditioning on brain and myocardium ischemia-reperfusion injury during coronary artery bypass graft surgery.

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Detailed Description

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60 patients scheduled to undergo coronary revascularization were recruited for this trial. Exclusion criteria included Emergency operation, age older than 80 years, learning difficulty, previous cerebrovascular disease, visual or hearing impairment, history of pneumothorax, Claustrophobia, middle ear disease, EF \< 35%. Patients were randomized either to the control group or hyperbaric oxygen group. The laboratory analysis of markers included S100B, NSE and troponin I. The assessment of cognitive dysfunction was performed 5 days before surgery and 7 days after surgery and haemodynamic measurements, length of stay in ICU, length of stay in hospital post-operation were recorded.

Conditions

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Brain Injury Myocardial Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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HBO

Group Type EXPERIMENTAL

Hyperbaric oxygen pretreatment (GR2200)

Intervention Type DEVICE

2 hours/day,5 days before surgery

Interventions

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Hyperbaric oxygen pretreatment (GR2200)

2 hours/day,5 days before surgery

Intervention Type DEVICE

Other Intervention Names

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GR2200

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo coronary revascularization surgery.

Exclusion Criteria

* Emergency operation
* Age older than 80 years
* Learning difficulty
* Previous cerebrovascular disease
* Visual or hearing impairment
* History of pneumothorax, claustrophobia, middle ear disease, EF \< 35%

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No