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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Bainbridge, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01166841
First received: June 8, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Mitral Regurgitation
 Procedure: PSVC line clamped

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Mean Near Infrared Saturation of the brain [ Time Frame: Baseline within 5 minutes of intervention then Intraoperatively during intervention. ] [ Designated as safety issue: Yes ]
    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:
  • Mean Blood Pressure [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.

  • Mean mixed venous saturation (non invasive measure) [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.

  • CPB pump flow [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.

  • Vacuum Pressure [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.

  • Venous reservoir level [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.

  • Arterial blood gas [ Time Frame: Initial, after first intervention arm(20 min), at end of study period (40 min) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline immediately before intervention period , end of each intervention period ] [ Designated as safety issue: No ]
    Score of 1-4 1=excellent visualization 4= poor visualization.

  • cerebral perfusion pressure [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.

  • Central Venous Pressure [ Time Frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period). ] [ Designated as safety issue: Yes ]
    Central venous pressure measured in the superior vena cava.


Enrollment: 35
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166841

Locations
Canada, Ontario
London Health Sciences Centre, Univeristy Hospital
London, Ontario, Canada, N6G 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Daniel Bainbridge, MD FRCPC Lawson Health research institute, University of Western Ontario
  More Information

No publications provided

Responsible Party: Daniel Bainbridge, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01166841     History of Changes
Other Study ID Numbers: R-10-181, 16992
Study First Received: June 8, 2010
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
minimally invasive cardiac surgery
cardiac surgery
near infrared spectroscopy
mitral valve repair
mitral valve replacement

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013