Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Not Applicable

Completed

• Conditions: Myocardial Injury; Brain Injury
• Interventions: Device: Hyperbaric oxygen pretreatment (GR2200)

• Registration Number: NCT00817791
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-08
• Study First Submitted: 2009-01-02
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Status Verified: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-06-12
• Last Update Posted: 2009-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBO	Hyperbaric oxygen pretreatment (GR2200)	-

Primary Outcome Measures

Name	Time	Method
Post operative cognitive dysfunction	5 days before surgery and 7 days after surgery

Secondary Outcome Measures

Name	Time	Method
S100B protein,NSE and Troponin I	Within the first 3 days after surgery