A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- ICU Admission Rate
研究概览
简要总结
This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients ≥ 18 years old
- •Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
- •Adult patients who are medically eligible to receive both anesthetics (GA and MAC)
排除标准
- •Inability to speak English
- •Body Mass Index (BMI) > 37 kg/m2
- •History of difficult airway requiring fiberoptic intubation
- •Inability to lie flat
- •Women who are pregnant
- •Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
- •Inability or unwillingness of subject to give informed consent based on any reason
- •Patients with any of the following absolute contraindications to TEE:
- •Perforated Viscus
- •Esophageal Stricture
- •Esophageal Tumor
- •Esophageal Perforation
- •Esophageal Diverticulum
- •Active upper GI Bleed
研究组 & 干预措施
Sedation
Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.
干预措施: Monitored anesthesia care (Procedure)
General
Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.
干预措施: General Endotracheal Anesthesia (Procedure)
结局指标
主要结局
ICU Admission Rate
时间窗: Up to 48 hours
The investigators will determine the ICU admission rate by taking the total number of patients admitted to the ICU and dividing it by the number of cases in each arm of the study, based on MUSC's "fast track" pathway and our inclusion.
Hospital Length of Stay
时间窗: Up to 1 month
The total number of hours that the patient stayed in the hospital will be measured from the "Anesthesia Start" time until their time of discharge, as recorded in their electronic medical record.
Procedural Mortality
时间窗: Up to 30 days
The percentage of the study population that died within 30 days of their procedure or during index procedure hospitalization - if the postoperative length of stay is longer than 30 days.
次要结局
- Paravalvular Regurgitation(For GETA cases, will be recorded after valve implantation. For all cases, will be recorded from a TTE report that is completed on post-operative day 1 or 2 and at 1 year.)
研究者
George Whitener
Principal Investigator
Medical University of South Carolina