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Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

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ClinicalTrials.gov Identifier: NCT00817791
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : June 15, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Brain Injury Myocardial Injury Device: Hyperbaric oxygen pretreatment (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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery
Study Start Date : November 2007
Primary Completion Date : August 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: HBO Device: Hyperbaric oxygen pretreatment (GR2200)
2 hours/day,5 days before surgery
Other Name: GR2200



Primary Outcome Measures :
  1. Post operative cognitive dysfunction [ Time Frame: 5 days before surgery and 7 days after surgery ]

Secondary Outcome Measures :
  1. S100B protein,NSE and Troponin I [ Time Frame: Within the first 3 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817791


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

Responsible Party: LZXiong,YLi, Department of Anaesthesiology,Xijing Hospital
ClinicalTrials.gov Identifier: NCT00817791     History of Changes
Other Study ID Numbers: liyang2007
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: March 2009

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

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