NCT00221663终止2 期
Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2002年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Forced expiratory volume and peak expiratory volume/second
研究概览
简要总结
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.
详细描述
Background:
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Design:
Randomized, single-blind, monocentric trial.
Interventions Compared:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of isolated aortic valvular replacement
- •Preoperative ASA class < = 3
- •Left ventricular ejection fraction > = 40%
- •Signed informed consent
排除标准
- •Aortic or mitral insufficiency > 3
- •History of cardiac surgery
- •Acute pulmonary edema
- •Endocarditis
- •Chronic renal insufficiency decompensation
- •Operative coagulation disorders regardless of etiology
结局指标
主要结局
Forced expiratory volume and peak expiratory volume/second
时间窗: at 48 hours
次要结局
- 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
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Valvular Surgery: Minimally Invasive vs Conventional SternotomyMinimally Invasive Cardiac Valvular SurgeryNCT04514315University of Calgary120
招募中
不适用
Studies in several research centers on video cardiac surgerycardiovascular surgical procedureRBR-6s7rw2Hospital São Francisco de Assis - HSFA
已完成
不适用
Combined SAPB in MICSSerratus Anterior Plane BlockAcute PainPostoperative AnalgesiaMinimal Invasive Cardiac SurgeryNCT06326320Ankara City Hospital Bilkent20
已完成
不适用
Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic SurgeryCardiac DiseaseSurgeryNCT03902717Jessa Hospital209
已完成
不适用
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) StudyLongstanding Persistent Atrial FibrillationPersistent Atrial FibrillationNCT01246466AtriCure, Inc.24