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

Primary Purpose

Mitral Regurgitation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PSVC line clamped
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation focused on measuring minimally invasive cardiac surgery, cardiac surgery, near infrared spectroscopy, mitral valve repair, mitral valve replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre, Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PSVC line clamped

Unclamped PSVC

Arm Description

Clamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.

Unclamped percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Blood Pressure
Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.
Mean mixed venous saturation (non invasive measure)
Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.
CPB pump flow
Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.
Vacuum Pressure
Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Venous reservoir level
Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.
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.
Surgical visualization score
Score of 1-4 1=excellent visualization 4= poor visualization.
cerebral perfusion pressure
Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.
Central Venous Pressure
Central venous pressure measured in the superior vena cava.

Full Information

First Posted
June 8, 2010
Last Updated
May 14, 2013
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01166841
Brief Title
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy in MICS
Acronym
NIRSinMICS
Official Title
The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
minimally invasive cardiac surgery, cardiac surgery, near infrared spectroscopy, mitral valve repair, mitral valve replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSVC line clamped
Arm Type
Experimental
Arm Description
Clamping of the percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.
Arm Title
Unclamped PSVC
Arm Type
No Intervention
Arm Description
Unclamped percutaneously placed superior vena cava line placed for minimally invasive mitral valve repair/replacement.
Intervention Type
Procedure
Intervention Name(s)
PSVC line clamped
Intervention Description
A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
Primary Outcome Measure Information:
Title
Mean Near Infrared Saturation of the brain
Description
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.
Time Frame
Baseline within 5 minutes of intervention then Intraoperatively during intervention.
Secondary Outcome Measure Information:
Title
Mean Blood Pressure
Description
Measure the Mean blood pressure during clamped/unclamped Percutaneous superior vena cava line placement.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
Mean mixed venous saturation (non invasive measure)
Description
Measure the central venous ressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
CPB pump flow
Description
Measure the pump flow during clamped/unclamped intervention of percutaneous superior vena cava line.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
Vacuum Pressure
Description
Measure the vacum pressure during clamped/unclamped intervention of percutaneous superior vena cava line.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
Venous reservoir level
Description
Measure the venous reservoir level during clamped/unclamped intervention of percutaneous superior vena cava line.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
Arterial blood gas
Description
Measure arterial blood gases at baseline at after each intervention clamped(20 min)/unclamped (20 min) of percutaneous superior vena cava line.
Time Frame
Initial, after first intervention arm(20 min), at end of study period (40 min)
Title
Surgical visualization score
Description
Score of 1-4 1=excellent visualization 4= poor visualization.
Time Frame
Baseline immediately before intervention period , end of each intervention period
Title
cerebral perfusion pressure
Description
Measure the cerebral perfusion pressure (MAP-CVP)during clamped/unclamped intervention of percutaneous superior vena cava line.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
Title
Central Venous Pressure
Description
Central venous pressure measured in the superior vena cava.
Time Frame
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bainbridge, MD FRCPC
Organizational Affiliation
Lawson Health research institute, University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre, Univeristy Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25440652
Citation
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.
Results Reference
derived

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

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