Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Valve Diseases
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Forced expiratory volume and peak expiratory volume/second
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Forced expiratory volume and peak expiratory volume/second
Time Frame: at 48 hours
Secondary Outcomes
- 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