Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00817791
First received: January 2, 2009
Last updated: June 12, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Brain Injury
Myocardial Injury
Device: Hyperbaric oxygen pretreatment (GR2200)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Post operative cognitive dysfunction [ Time Frame: 5 days before surgery and 7 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • S100B protein,NSE and Troponin I [ Time Frame: Within the first 3 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBO Device: Hyperbaric oxygen pretreatment (GR2200)
2 hours/day,5 days before surgery
Other Name: GR2200

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00817791

Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: xiong L Z, doctor Department of anaesthiology,Xijing hospital
  More Information

No publications provided

Responsible Party: LZXiong,YLi, Department of Anaesthesiology,Xijing Hospital
ClinicalTrials.gov Identifier: NCT00817791     History of Changes
Other Study ID Numbers: liyang2007
Study First Received: January 2, 2009
Last Updated: June 12, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
CABG
hyperbaric oxygen
preconditioning
S100B
NSE
Troponin I
CABG surgery
neuroprotection

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014