Brain InjuryNCT00817791
Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery
A study testing Hyperbaric oxygen pretreatment (GR2200) in people with Brain Injury and Myocardial Injury, run by Xijing Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Brain Injury, Myocardial Injury
- What is being tested?
- Hyperbaric oxygen pretreatment (GR2200)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo coronary revascularization surgery.
Who cannot join
- 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%
About this study
Official title: Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG 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.
Read the 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.
- Conditions
- Brain Injury, Myocardial Injury
- Being tested
- Hyperbaric oxygen pretreatment (GR2200)
- Keywords
- CABG, hyperbaric oxygen, preconditioning, S100B, NSE, Troponin I, CABG surgery, neuroprotection
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen pretreatment (GR2200)Device
Also called GR2200
2 hours/day,5 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| HBO | Experimental | Not described Receives: Device: Hyperbaric oxygen pretreatment (GR2200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative cognitive dysfunction
Measured: 5 days before surgery and 7 days after surgery
Secondary outcomes (1)
S100B protein,NSE and Troponin I
Measured: Within the first 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- xiong L Z, doctor, Study chair, Department of anaesthiology,Xijing hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817791
- Sponsor's protocol ID
- liyang2007
- Status last verified
- Mar 2009
- First submitted
- 2 Jan 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery
- ClinicalTrials.gov ID
- NCT00817791
- Acronym / sponsor ID
- liyang2007
- Conditions
- Brain Injury, Myocardial Injury
- Keywords
- CABG, hyperbaric oxygen, preconditioning, S100B, NSE, Troponin I, CABG surgery, neuroprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBO | Experimental | Device: Hyperbaric oxygen pretreatment (GR2200) |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo coronary revascularization surgery.
Key exclusion criteria (6 listed)
- Emergency operation
- Age older than 80 years
- Learning difficulty
- Previous cerebrovascular disease
- Visual or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen pretreatment (GR2200)Also: GR22002 hours/day,5 days before surgery | Device | HBO |
Primary outcome
Post operative cognitive dysfunction
Time frame: 5 days before surgery and 7 days after surgery
1 secondary outcome
S100B protein,NSE and Troponin I
Time frame: Within the first 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiong L Z, doctor study chair
Department of anaesthiology,Xijing hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen pretreatment (GR2200) in people with Brain Injury and Myocardial Injury, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative cognitive dysfunction (time frame: 5 days before surgery and 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2009; AzTrials last refreshed its copy on 3 Nov 2026.