Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817791
• Other study ID #: liyang2007
• Status: Completed
• Phase: N/A
• First received: January 2, 2009
• Last updated: June 12, 2009
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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%

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Myocardial Injury
• Wounds and Injuries

Intervention

Device:
• Hyperbaric oxygen pretreatment (GR2200)
2 hours/day,5 days before surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative cognitive dysfunction		5 days before surgery and 7 days after surgery
Secondary	S100B protein,NSE and Troponin I		Within the first 3 days after surgery