NCT00817791

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 15, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

January 2, 2009

Last Update Submit

June 12, 2009

Conditions

Brain InjuryMyocardial Injury

Keywords

CABGhyperbaric oxygenpreconditioningS100BNSETroponin ICABG surgeryneuroprotection

Outcome Measures

Primary Outcomes (1)

  • Post operative cognitive dysfunction

    5 days before surgery and 7 days after surgery

Secondary Outcomes (1)

  • S100B protein,NSE and Troponin I

    Within the first 3 days after surgery

Study Arms (1)

HBO

EXPERIMENTAL
Device: Hyperbaric oxygen pretreatment (GR2200)

Interventions

Hyperbaric oxygen pretreatment (GR2200)DEVICE

2 hours/day,5 days before surgery

Also known as: GR2200
HBO

Eligibility Criteria

AgeUp to 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo coronary revascularization surgery.

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • xiong L Z, doctor

    Department of anaesthiology,Xijing hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 6, 2009

Study Start

November 1, 2007

Primary Completion

August 1, 2008

Study Completion

March 1, 2009

Last Updated

June 15, 2009

Record last verified: 2009-03