Clinical trial NCT01166841: The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS
Official title: The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Keywords: minimally invasive cardiac surgery
cardiac surgery
near infrared spectroscopy
mitral valve repair
mitral valve replacement
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Emergency surgery

Primary outcomes:
measure: Mean Near Infrared Saturation of the brain
timeFrame: Baseline within 5 minutes of intervention then Intraoperatively during intervention.
Secondary outcomes:
measure: Mean Blood Pressure
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: Mean mixed venous saturation (non invasive measure)
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: CPB pump flow
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: Vacuum Pressure
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: Venous reservoir level
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: Arterial blood gas
timeFrame: Initial, after first intervention arm(20 min), at end of study period (40 min)
measure: Surgical visualization score
timeFrame: Baseline immediately before intervention period , end of each intervention period
measure: cerebral perfusion pressure
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
measure: Central Venous Pressure
timeFrame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, Univeristy Hospital
state: Ontario
Study officials:
affiliation: Lawson Health research institute, University of Western Ontario
name: Daniel Bainbridge, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.