NCT03084978撤回不适用
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time-on-table
研究概览
简要总结
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
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
- Double (Participant, 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
- 否
入选标准
- •Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
- •Age over 18 years of age.
- •Women of child bearing age must have a negative urine or serum pregnancy test.
- •Clinical indication for a transfemoral aortic valve replacement.
- •English or Spanish speaking
- •No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
排除标准
- •Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
- •High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
- •Inability to lie supine for more than 30 minutes.
- •Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
- •Patient refusal
- •Patient involved in another research study
- •Psychiatric condition precluding ability to provide informed consent
- •History of clinical stroke within 3 months prior to randomization
研究组 & 干预措施
General Anesthesia
Active Comparator
Subjects will undergo general anesthesia with endotracheal intubation.
干预措施: General Anesthesia (Procedure)
Conscious Sedation
Experimental
Subjects will undergo conscious sedation anesthesia.
干预措施: Conscious Sedation (Procedure)
结局指标
主要结局
Time-on-table
时间窗: <1 day
* time to patient on table to surgical drapes down * time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
次要结局
- Number of patients with serious adverse events(within 30 days)
- Length of stay(within 30 days)
- Readmissions(within 30 days)
- Number of Patients with Valve Complications(within 30 days)
- Contrast usage(<1 day)
- Fluoroscopy time(<1 day)
研究者
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