Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2000-05 |
Not provided
Not provided
Not provided
slow recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery techniques (sternotomy for aortic valve replacement) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume and peak expiratory volume/second | at 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume | at 24 hours | |
| Peak expiratory volume/s at 24 hours | ||
| Pro-inflammatory cytokines on tracheal aspiration samples |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gerard Janvier, Pr | University Hospital, Bordeaux | Principal Investigator |
| Joachim Calderon, Dr | University Hospital, Bordeaux France | Principal Investigator |
| Geneviéve Chene, Pr | University Hospital, Bordeaux France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cardiologique du Haut Lévêque | Pessac | 33604 | France |
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D056346 | Sternotomy |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |