Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Patient Satisfaction: survey
研究概览
简要总结
The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.
详细描述
After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.
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
- None
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
- •18 years of age or older,
- •patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
- •ability to provide written informed consent
排除标准
- •Age less than 18 years
- •emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
- •patients not alert and oriented to person, place, and date,
- •concurrent surgical procedures on the day of TAVR or arrhythmia ablation.
研究组 & 干预措施
Strict NPO
NPO after midnight. No solids or liquids after midnight.
干预措施: NPO past midnight (Other)
Liberal NPO
No solids after midnight. Clear liquids up to 2 hours prior to surgery.
干预措施: NPO (Other)
结局指标
主要结局
Patient Satisfaction: survey
时间窗: Up to 24 hours
The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.
次要结局
- Exploratory Analyses(Through the end of hospitalization, usually 2 days.)
研究者
Derek Atkinson
Cardiac Anesthesiologist
Stony Brook University