Elective Off-pump Coronary Artery Bypass GraftingNCT01673841
Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.
An observational study of Elective Off-pump Coronary Artery Bypass Grafting, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to… Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Elective Off-pump Coronary Artery Bypass Grafting
- What is being tested?
- Relative and absolute cerebral oxygen saturation (rScO2) measurements.
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2009to Jun 2011
- Phase
- Observational
- 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 25 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective off-pump coronary artery bypass grafting.
Who may be able to join
- Patients undergoing elective off-pump coronary artery bypass grafting for at least 3-vessel coronary artery disease were eligible.
Who cannot join
- Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of > 60% were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.
42 consenting patients undergoing elective off-pump coronary artery bypass grafting were included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed just above the eyebrows, and the sensors of the other monitor were placed just above the former sensors. The sensors placement was determined at random by a computerized randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All variables were recorded continuously. The study ended at the end of the operation.
- Being tested
- Relative and absolute cerebral oxygen saturation (rScO2) measurements.
- Keywords
- bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative and absolute cerebral oxygen saturation (rScO2) measurements.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Relative + absolute cerebral oxygen saturation. | Not described Receives: Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.
Mixed venous oxygen saturation was measured continuously via a pulmonary artery catheter. Cerebral oxygen saturation was measured with near-infrared spectroscopy; the INVOS monitor to obtain relative measurements, and the Foresight monitor to obtain absolute data.
Measured: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).
Secondary outcomes (1)
The response of cerebral oxygen saturation to major haemodynamic disturbances.
Percentage difference between the cerebral oxygen saturation value just before heart retraction and the value at the different time moments.
Measured: 2 hours after start of operation (during placement of deep pericardial stitches).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Off-pump Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Foundation for Cardiac Surgery, CAS Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Annelies Moerman, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673841
- Sponsor's protocol ID
- 2009/126
- Status last verified
- Jul 2021
- First submitted
- 17 Aug 2012
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT01673841
- Acronym / sponsor ID
- 2009/126
- Keywords
- bypass grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Belgian Foundation for Cardiac Surgery, CAS Medical Systems, Inc.
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Aug 2012 (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.
In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.
42 consenting patients undergoing elective off-pump coronary artery bypass grafting were included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed just above the eyebrows, and the sensors of the other monitor were placed just above the former sensors. The sensors placement was determined at random by a computerized randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All variables were recorded continuously. The study ended at the end of the operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relative + absolute cerebral oxygen saturation. | – | Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective off-pump coronary artery bypass grafting.
Key inclusion criteria (1 listed)
- Patients undergoing elective off-pump coronary artery bypass grafting for at least 3-vessel coronary artery disease were eligible.
Key exclusion criteria (1 listed)
- Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of > 60% were excluded.
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 |
|---|---|---|
| Relative and absolute cerebral oxygen saturation (rScO2) measurements. | Procedure or surgery | Relative + absolute cerebral oxygen saturation. |
Primary outcome
Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.
Time frame: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).
Mixed venous oxygen saturation was measured continuously via a pulmonary artery catheter. Cerebral oxygen saturation was measured with near-infrared spectroscopy; the INVOS monitor to obtain relative measurements, and the Foresight monitor to obtain absolute data.
1 secondary outcome
The response of cerebral oxygen saturation to major haemodynamic disturbances.
Time frame: 2 hours after start of operation (during placement of deep pericardial stitches).
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 13 Jul 2021.
- Related InfoLink provided by the sponsor.
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.
Annelies Moerman, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Off-pump Coronary Artery Bypass Grafting, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting. (time frame: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).). 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 13 Jul 2021.