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

Mitral Regurgitation Clinical Trial

— NIRSinMICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166841
• Other study ID #: R-10-181
• Secondary ID: 16992
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: May 14, 2013
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• PSVC line clamped
A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, Univeristy Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline within 5 minutes of intervention then Intraoperatively during intervention.	Yes
Secondary	Mean Blood Pressure	Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	Mean mixed venous saturation (non invasive measure)	Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	CPB pump flow	Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	Vacuum Pressure	Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	Venous reservoir level	Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	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.	Initial, after first intervention arm(20 min), at end of study period (40 min)	Yes
Secondary	Surgical visualization score	Score of 1-4 1=excellent visualization 4= poor visualization.	Baseline immediately before intervention period , end of each intervention period	No
Secondary	cerebral perfusion pressure	Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes
Secondary	Central Venous Pressure	Central venous pressure measured in the superior vena cava.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).	Yes