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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient Specific Mitral Valve Modeling for Surgical Planning and Training

NCT03609931

Mitral Valve Prolapse Mitral Regurgitation Mitral Valve Disease

UNKNOWN

Magnetic Resonance Imaging for Cerebral Embolization During Minimal Invasive Mitral Valve Surgery

NCT02818166

Neurological Complications Mitral Valve Insufficiency

UNKNOWN NA

Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention

NCT01156441

Myocardial Infarction Mitral Regurgitation

WITHDRAWN PHASE1/PHASE2

Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation

NCT00806988

Mitral Valve Insufficiency Coronary Artery Disease

COMPLETED NA

Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation

NCT00807040

Mitral Valve Insufficiency Coronary Artery Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PSVC line clamped

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

Group Type EXPERIMENTAL

PSVC line clamped

Intervention Type PROCEDURE

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

Unclamped PSVC

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PSVC line clamped

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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