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

May 14, 2013 updated by: Daniel Bainbridge, Lawson Health Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline within 5 minutes of intervention then Intraoperatively during intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Initial, after first intervention arm(20 min), at end of study period (40 min)
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.
Baseline immediately before intervention period , end of each intervention period
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).
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.
Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Bainbridge, MD FRCPC, Lawson Health research institute, University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-10-181
  • 16992 (REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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