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

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Procedure: PSVC line clamped

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 5A5
      • London Health Sciences Centre, Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSVC line clamped; Clamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.	Procedure: PSVC line clamped; A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
No Intervention: Unclamped PSVC; Unclamped percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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)
Surgical visualization score	Score of 1-4 1=excellent visualization 4= poor visualization.	Baseline immediately before intervention period , end of each intervention period
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).
Central Venous Pressure	Central venous pressure measured in the superior vena cava.	Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Daniel Bainbridge, MD FRCPC, Lawson Health research institute, University of Western Ontario

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: cardiac surgery; mitral valve repair; mitral valve replacement; near infrared spectroscopy; minimally invasive cardiac surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: R-10-181; 16992 (REB)