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

Study Overview
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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.

Official Title
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The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury

Conditions
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Myocardial Reperfusion Injury, Cytoprotection

Intervention / Treatment
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* Drug: Hyperbaric Oxygen


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Patients in this arm were not treated with HBO prior to CABG | |
| Experimental: B<br>Patients in this arm were treated with HBO prior to CABG | Drug: Hyperbaric Oxygen<br>* 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<br>* Other names: Hyperbaric Oxygen Preconditioning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Hsp72 protein |  | Intra-operative (During CABG) | 
| Myocardial eNOS protein |  | Intra-Operative (During CABG) | 
| Serum Troponin-T |  | Peri-operative | 
| Serum soluble ICAM-1 |  | Peri-operative | 
| Serum soluble PSGL-1 |  | Peri-operative | 
| Serum soluble P-Selectin |  | Peri-operative | 
| Serum soluble E-Selectin |  | Peri-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter |  | Peri-operative | 
| Duration of mechanical ventilation |  | Post Operative | 
| Duration of endotracheal intubation |  | post operative | 
| Length of stay in ICU |  | Post-operative | 
| Blood loss |  | Post operative | 
| Inotrope usage |  | Post operative | 
| Atrial Fibrillation |  | Post operative | 
| Low cardiac output status |  | Post operative | 
| Pulmonary complications |  | Post operative | 
| Renal Complications |  | Post operative | 
| Cerebrovascular complications |  | Post operative | 
| Gastrointestinal complications |  | Post operative | 
| Wound complications |  | Post operative | 
| Cost of ICU stay |  | Post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial protection, Ischemic Reperfusion Injury, Hyperbaric Oxygen, Preconditioning