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Completed

NCT Number: NCT01166841

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, Univeristy Hospital

London, Ontario, N6G 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSVC line clamped

Procedure

A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.

Primary outcomes

  1. Mean Near Infrared Saturation of the brain

    Time frame: 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 outcomes

  1. Mean Blood Pressure

    Time frame: 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.

  2. Mean mixed venous saturation (non invasive measure)

    Time frame: 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.

  3. CPB pump flow

    Time frame: 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.

  4. Vacuum Pressure

    Time frame: 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.

  5. Venous reservoir level

    Time frame: 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.

  6. Arterial blood gas

    Time frame: 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.

  7. Surgical visualization score

    Time frame: Baseline immediately before intervention period , end of each intervention period

    Score of 1-4 1=excellent visualization 4= poor visualization.

  8. cerebral perfusion pressure

    Time frame: 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.

  9. Central Venous Pressure

    Time frame: Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).

    Central venous pressure measured in the superior vena cava.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Acronym: NIRSinMICS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 21, 2010
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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