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The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS

The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166841
Acronym
NIRSinMICS
Enrollment
35
Registered
2010-07-21
Start date
2010-05-31
Completion date
2011-09-30
Last updated
2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

minimally invasive cardiac surgery, cardiac surgery, near infrared spectroscopy, mitral valve repair, mitral valve replacement

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.

Interventions

PROCEDUREPSVC line clamped

A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Near Infrared Saturation of the brainBaseline 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.

Secondary

MeasureTime frameDescription
Mean Blood PressureIntraoperatively during intervention.(every 5 minutes during 40 minute intervention period).Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.
Mean mixed venous saturation (non invasive measure)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.
CPB pump flowIntraoperatively during intervention.(every 5 minutes during 40 minute intervention period).Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.
Vacuum PressureIntraoperatively during intervention.(every 5 minutes during 40 minute intervention period).Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Venous reservoir levelIntraoperatively 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.
Surgical visualization scoreBaseline immediately before intervention period , end of each intervention periodScore of 1-4 1=excellent visualization 4= poor visualization.
cerebral perfusion pressureIntraoperatively 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.
Central Venous PressureIntraoperatively during intervention.(every 5 minutes during 40 minute intervention period).Central venous pressure measured in the superior vena cava.
Arterial blood gasInitial, 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026