A Randomized Trial of Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)
研究概览
简要总结
Moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. Whether being in a fasting state (nothing per os, NPO) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. Whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time.
We aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept NPO prior to cardiac catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Requiring a cardiac catheterization as per standard of care
- •Elective procedure with planned moderate sedation
排除标准
- •All emergent procedures
- •All mechanical circulatory support-assisted procedures
- •Other high risk procedures (as identified by the operator)
- •Pregnant women
- •Hemodynamically unstable patients
- •Active GI illness, including nausea at the time of screening
- •Taking chronic pain medications at home or on current brief course of narcotics
- •Encephalopathy
- •Patients scheduled for deep sedation
- •Severe GERD (if the patient requires more than one medication for adequate control of GERD symptoms or has required medical intervention within the past year)
研究组 & 干预措施
Fasting group
Participant will be asked to fast at least 6 hours prior to the procedure
干预措施: Coronary angiogram (Procedure)
Fasting group
Participant will be asked to fast at least 6 hours prior to the procedure
干预措施: Right heart catheterization (Procedure)
Non-Fasting group
Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
干预措施: Coronary angiogram (Procedure)
Non-Fasting group
Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
干预措施: Right heart catheterization (Procedure)
结局指标
主要结局
Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)
时间窗: Baseline (Prior to procedure)
We get a wellness score prior to the procedure (right before the patient is taken into the lab) and is on a 0-5 scale with 0 being very happy and 5 being very unhappy.
Intra- and post-procedural vomiting, aspiration, and intubation checklist
时间窗: Within 24 hours after the procedure
We review the chart and ask the participant if they had any vomiting. We also review the chart to see if there are any reports/concern of aspiration and follow up on any chest X-rays that were obtained.
次要结局
未报告次要终点