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

Not Applicable

Completed

• Conditions: Mitral Regurgitation
• Interventions: Procedure: PSVC line clamped

• Registration Number: NCT01166841
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSVC line clamped	PSVC line clamped	Clamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.

Primary Outcome Measures

Name	Time	Method
Mean Near Infrared Saturation of the brain	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.

Secondary Outcome Measures

Name	Time	Method
Mean Blood Pressure	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.
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 flow	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.
Vacuum Pressure	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.
Venous reservoir level	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.
Arterial blood gas	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.
Surgical visualization score	Baseline immediately before intervention period , end of each intervention period	Score of 1-4 1=excellent visualization 4= poor visualization.
cerebral perfusion pressure	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.
Central Venous Pressure	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Central venous pressure measured in the superior vena cava.

Trial Locations

Locations (1)

London Health Sciences Centre, Univeristy Hospital; 🇨🇦 London, Ontario, Canada