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

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NHS Trust

Status and phase

Completed
Phase 2
Phase 1

Conditions

Myocardial Reperfusion Injury
Cytoprotection

Treatments

Drug: Hyperbaric Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT00623142
04/Q1104/26
R0047

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

81 participants in 2 patient groups

A
No Intervention group
Description:
Patients in this arm were not treated with HBO prior to CABG
B
Experimental group
Description:
Patients in this arm were treated with HBO prior to CABG
Treatment:
Drug: Hyperbaric Oxygen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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