Trials / Completed
CompletedNCT00817791
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Xijing Hospital · Academic / Other
- Sex
- Male
- Age
- 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hyperbaric oxygen pretreatment (GR2200) | 2 hours/day,5 days before surgery |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-08-01
- Completion
- 2009-03-01
- First posted
- 2009-01-06
- Last updated
- 2009-06-15
Source: ClinicalTrials.gov record NCT00817791. Inclusion in this directory is not an endorsement.