The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart 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

PHASE1/PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG.

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Detailed Description

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Conditions

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Myocardial Reperfusion Injury Cytoprotection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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A

Patients in this arm were not treated with HBO prior to CABG

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Patients in this arm were treated with HBO prior to CABG

Group Type EXPERIMENTAL

Hyperbaric Oxygen

Intervention Type DRUG

100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG

Interventions

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Hyperbaric Oxygen

100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG

Intervention Type DRUG

Other Intervention Names

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Hyperbaric Oxygen Preconditioning

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective first time CABG
* Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG

Exclusion Criteria

* Age ≤ 20 years or ≥ 85 years
* Ejection fraction \< 30%
* Unstable angina
* Recent myocardial infarction (\< 1 month)
* Any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure)
* Any end stage organ failure (e.g. renal and respiratory failure)
* History of chronic obstructive pulmonary disease (COPD)
* Pneumothorax
* Pulmonary bullae
* Convulsions
* Current history of malignancy
* Severe myopia or intraocular lens
* Patients on K+(ATP) Channel Openers e.g. Nicorandil, Oral Hypoglycemics, Opioid Analgesics, Catecholamines.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No