London Health Sciences Centre, Univeristy Hospital
London, Ontario, N6G 5A5, Canada
NCT Number: NCT01166841
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
London, Ontario, N6G 5A5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
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.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.
Time frame: Initial, after first intervention arm(20 min), at end of study period (40 min)
Measure arterial blood gases at baseline at after each intervention clamped(20 min)/unclamped (20 min) of percutaneous superior vena cava line.
Time frame: Baseline immediately before intervention period , end of each intervention period
Score of 1-4 1=excellent visualization 4= poor visualization.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.
Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Central venous pressure measured in the superior vena cava.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery
Acronym: NIRSinMICS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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