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

NCT01166841 | Completed

• 2 other identifiers: R-10-18116992
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Keywords

minimally invasive cardiac surgery; cardiac surgery; near infrared spectroscopy; mitral valve repair; mitral valve replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean Blood Pressure

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

• Mean mixed venous saturation (non invasive measure)

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

• CPB pump flow

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

• Vacuum Pressure

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

• Venous reservoir level

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

Study Arms (2)

PSVC line clamped

EXPERIMENTAL

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

Procedure: PSVC line clamped

Unclamped PSVC

NO INTERVENTION

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

Interventions

PSVC line clamped PROCEDURE

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

PSVC line clamped

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Elective mitral valve repair or replacement.
• Scheduled to have minimally invasive approach (right thoracotomy)
• No contraindication to SVC line placement

You may not qualify if:

• Emergency surgery

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre, Univeristy Hospital

London, Ontario, N6G 5A5, Canada

Location

Related Publications (1)

• 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.

  PMID: 25440652 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Daniel Bainbridge, MD FRCPC

  Lawson Health research institute, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: July 21, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

CA (1)