Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817791

Enrollment

Registered

2009-01-06

Start date

2007-11-30

Completion date

2009-03-31

Last updated

2009-06-15

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

Conditions

Brain Injury, Myocardial Injury

Keywords

CABG, hyperbaric oxygen, preconditioning, S100B, NSE, Troponin I, CABG surgery, neuroprotection

Brief summary

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.

Detailed description

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.

Interventions

DEVICEHyperbaric oxygen pretreatment (GR2200)

2 hours/day,5 days before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

MALE

Age

No minimum to 80 Years

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
Post operative cognitive dysfunction	5 days before surgery and 7 days after surgery

Secondary

Measure	Time frame
S100B protein,NSE and Troponin I	Within the first 3 days after surgery

Outcome results

None listed

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