Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Study Overview
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Brief Summary
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Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

Detailed Description
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Background: Minimally invasive techniques for cardiac surgery should be formally evaluated. Design: Randomized, single-blind, monocentric trial. Interventions Compared: Median sternotomy versus minimally invasive technique. Eligibility Criteria: Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%. Primary Outcome: Forced expiratory volume and peak expiratory volume/second at 48 hours.

Official Title
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Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: surgery techniques (sternotomy for aortic valve replacement)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication of isolated aortic valvular replacement Preoperative ASA class < = 3 Left ventricular ejection fraction > = 40% Signed informed consent Exclusion Criteria: Aortic or mitral insufficiency > 3 History of cardiac surgery Acute pulmonary edema Endocarditis Chronic renal insufficiency decompensation Operative coagulation disorders regardless of etiology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: surgery techniques (sternotomy for aortic valve replacement)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume and peak expiratory volume/second |  | at 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume |  | at 24 hours | 
| Peak expiratory volume/s at 24 hours |  |  | 
| Pro-inflammatory cytokines on tracheal aspiration samples |  |  | 
| Transfusion requirements during the first 24 hours post operative |  |  | 
| Hemodynamic parameters |  |  | 
| Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time |  |  | 
| Consumption of analgetics |  |  | 
| Morbidity and mortality during hospital stay |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Aortic valve replacement, Minimally invasive surgery, Perioperative course