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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00623142
Enrollment
81
Registered
2008-02-25
Start date
2005-01-31
Completion date
2008-01-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytoprotection, Myocardial Reperfusion Injury

Keywords

Myocardial protection, Ischemic Reperfusion Injury, Hyperbaric Oxygen, Preconditioning

Brief summary

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.

Interventions

DRUGHyperbaric 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

Sponsors

North of England Medical & Hyperbaric Services
CollaboratorUNKNOWN
Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Myocardial Hsp72 proteinIntra-operative (During CABG)
Myocardial eNOS proteinIntra-Operative (During CABG)
Serum Troponin-TPeri-operative
Serum soluble ICAM-1Peri-operative
Serum soluble PSGL-1Peri-operative
Serum soluble P-SelectinPeri-operative
Serum soluble E-SelectinPeri-operative

Secondary

MeasureTime frame
Low cardiac output statusPost operative
Pulmonary complicationsPost operative
Renal ComplicationsPost operative
All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheterPeri-operative
Gastrointestinal complicationsPost operative
Wound complicationsPost operative
Cost of ICU stayPost operative
Cerebrovascular complicationsPost operative
Duration of mechanical ventilationPost Operative
Duration of endotracheal intubationpost operative
Length of stay in ICUPost-operative
Blood lossPost operative
Inotrope usagePost operative
Atrial FibrillationPost operative

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026