search
Back to results

Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Primary Purpose

Brain Injury, Myocardial Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperbaric oxygen pretreatment (GR2200)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Injury focused on measuring CABG, hyperbaric oxygen, preconditioning, S100B, NSE, Troponin I, CABG surgery, neuroprotection

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HBO

    Arm Description

    Outcomes

    Primary Outcome Measures

    Post operative cognitive dysfunction

    Secondary Outcome Measures

    S100B protein,NSE and Troponin I

    Full Information

    First Posted
    January 2, 2009
    Last Updated
    June 12, 2009
    Sponsor
    Xijing Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00817791
    Brief Title
    Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery
    Official Title
    Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Xijing Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injury, Myocardial Injury
    Keywords
    CABG, hyperbaric oxygen, preconditioning, S100B, NSE, Troponin I, CABG surgery, neuroprotection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HBO
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Hyperbaric oxygen pretreatment (GR2200)
    Other Intervention Name(s)
    GR2200
    Intervention Description
    2 hours/day,5 days before surgery
    Primary Outcome Measure Information:
    Title
    Post operative cognitive dysfunction
    Time Frame
    5 days before surgery and 7 days after surgery
    Secondary Outcome Measure Information:
    Title
    S100B protein,NSE and Troponin I
    Time Frame
    Within the first 3 days after surgery

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    xiong L Z, doctor
    Organizational Affiliation
    Department of anaesthiology,Xijing hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

    We'll reach out to this number within 24 hrs