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Completed

NCT Number: NCT00817791

Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Myocardial Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Hyperbaric oxygen pretreatment (GR2200)

Device

2 hours/day,5 days before surgery

Other names: GR2200

Primary outcomes

  1. Post operative cognitive dysfunction

    Time frame: 5 days before surgery and 7 days after surgery

Secondary outcomes

  1. S100B protein,NSE and Troponin I

    Time frame: Within the first 3 days after surgery

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Jun 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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