Mitral RegurgitationNIRSinMICSNCT01166841
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS
A study testing PSVC line clamped in people with Mitral Regurgitation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. This avoids the use of a sternotomy incision through the bone in the front of the chest. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- PSVC line clamped
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Sep 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- Elective mitral valve repair or replacement.
- Scheduled to have minimally invasive approach (right thoracotomy)
- No contraindication to SVC line placement
Who cannot join
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, Univeristy Hospital
London, Ontario, N6G 5A5
About this study
Official title: The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery
The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. This avoids the use of a sternotomy incision through the bone in the front of the chest. The benefits of such an approach are cosmetic (smaller incision not easily visible) and faster recovery. The minimally invasive approach also eliminates the risk of sternal wound infection. Minimally invasive cardiac surgery however poses additional challenges; one of the biggest is access to the large blood vessels which need to be cannulated to allow the heart lung machine to function. In conventional surgery, these vessels are easily accessed as they are entering or leaving the heart. In minimally invasive surgery, the cannula are placed into easily accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller than those by the heart and so require smaller cannula, which provide challenges to the heart lung machine. One way around this is to use more cannulae and so cannulation of a vein in the neck is also performed. This cannula however, has been associated with neck hematoma, tearing of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC now, when this surgery was first performed here 10 years ago, it was done so without the neck cannula and with no injury to patients. The purpose of this study therefore, is to more rigorously study the effect of the neck cannula on heart lung bypass, and more specifically to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid hypoxia.
- Conditions
- Mitral Regurgitation
- Being tested
- PSVC line clamped
- Keywords
- minimally invasive cardiac surgery, cardiac surgery, near infrared spectroscopy, mitral valve repair, mitral valve replacement
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSVC line clampedProcedure or surgery
A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| PSVC line clamped | Experimental | Clamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement. Receives: Procedure: PSVC line clamped |
| Unclamped PSVC | No intervention | Unclamped percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Near Infrared Saturation of the brain
Measure the NIRs of the brain by placeing NIRs monitoring patches on the forehead during clamped and unclamped intervention of the percutaneous superior vena cava line.
Measured: Baseline within 5 minutes of intervention then Intraoperatively during intervention.
Secondary outcomes (9)
Mean Blood Pressure
Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Mean mixed venous saturation (non invasive measure)
Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
CPB pump flow
Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Vacuum Pressure
Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Venous reservoir level
Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Arterial blood gas
Measure arterial blood gases at baseline at after each intervention clamped(20 min)/unclamped (20 min) of percutaneous superior vena cava line.
Measured: Initial, after first intervention arm(20 min), at end of study period (40 min)
Surgical visualization score
Score of 1-4 1=excellent visualization 4= poor visualization.
Measured: Baseline immediately before intervention period , end of each intervention period
cerebral perfusion pressure
Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Central Venous Pressure
Central venous pressure measured in the superior vena cava.
Measured: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bainbridge, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Daniel Bainbridge, MD FRCPC, Principal investigator, Lawson Health research institute, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166841
- Sponsor's protocol ID
- R-10-181
- Other IDs
- 16992
- Acronym
- NIRSinMICS
- Status last verified
- May 2013
- First submitted
- 8 Jun 2010
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bainbridge DT, Chu MW, Kiaii B, Cleland A, Murkin J. Percutaneous superior vena cava drainage during minimally invasive mitral valve surgery: a randomized, crossover study. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):101-6. doi: 10.1053/j.jvca.2014.07.020. Epub 2014 Nov 7.
PubMed 25440652
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT01166841
- Acronym / sponsor ID
- NIRSinMICS / R-10-181
- Conditions
- Mitral Regurgitation
- Keywords
- minimally invasive cardiac surgery, cardiac surgery, near infrared spectroscopy, mitral valve repair, mitral valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Jul 2010 (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.
The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. This avoids the use of a sternotomy incision through the bone in the front of the chest. The benefits of such an approach are cosmetic (smaller incision not easily visible) and faster recovery. The minimally invasive approach also eliminates the risk of sternal wound infection. Minimally invasive cardiac surgery however poses additional challenges; one of the biggest is access to the large blood vessels which need to be cannulated to allow the heart lung machine to function. In conventional surgery, these vessels are easily accessed as they are entering or leaving the heart. In minimally invasive surgery, the cannula are placed into easily accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller than those by the heart and so require smaller cannula, which provide challenges to the heart lung machine. One way around this is to use more cannulae and so cannulation of a vein in the neck is also performed. This cannula however, has been associated with neck hematoma, tearing of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC now, when this surgery was first performed here 10 years ago, it was done so without the neck cannula and with no injury to patients. The purpose of this study therefore, is to more rigorously study the effect of the neck cannula on heart lung bypass, and more specifically to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSVC line clamped | Experimental | Procedure: PSVC line clampedClamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement. |
| Unclamped PSVC | No intervention | –Unclamped percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years of age
- Elective mitral valve repair or replacement.
- Scheduled to have minimally invasive approach (right thoracotomy)
- No contraindication to SVC line placement
Key exclusion criteria (1 listed)
- Emergency surgery
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 |
|---|---|---|
| PSVC line clampedA line clamp will be placed on the PSVC line while on cardiopulmonary bypass. | Procedure or surgery | PSVC line clamped |
Primary outcome
Mean Near Infrared Saturation of the brain
Time frame: Baseline within 5 minutes of intervention then Intraoperatively during intervention.
Measure the NIRs of the brain by placeing NIRs monitoring patches on the forehead during clamped and unclamped intervention of the percutaneous superior vena cava line.
9 secondary outcomes
Mean Blood Pressure
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Mean mixed venous saturation (non invasive measure)
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
CPB pump flow
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Vacuum Pressure
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Venous reservoir level
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Arterial blood gas
Time frame: Initial, after first intervention arm(20 min), at end of study period (40 min)
Surgical visualization score
Time frame: Baseline immediately before intervention period , end of each intervention period
cerebral perfusion pressure
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Central Venous Pressure
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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 May 2013.
- Derived from this study: PubMed 25440652Bainbridge DT, Chu MW, Kiaii B, Cleland A, Murkin J. Percutaneous superior vena cava drainage during minimally invasive mitral valve surgery: a randomized, crossover study. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):101-6. doi: 10.1053/j.jvca.2014.07.020. Epub 2014 Nov 7.
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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.
Daniel Bainbridge, MD FRCPC principal investigator
Lawson Health research institute, University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSVC line clamped in people with Mitral Regurgitation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 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 15 May 2013. 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 Canada. 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?
Mean Near Infrared Saturation of the brain (time frame: Baseline within 5 minutes of intervention then Intraoperatively during intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01166841, which also lists 1 linked publication.
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 May 2013.