Benefits of no FASTing Prior to Elective Cardiac CATHeterization (FAST CATH): A Single-center Randomized-controlled Trial Comparing a Non-fasting Pre-procedure Approach to the Standard of Care in Adults Undergoing Elective Cardiac Catheterization With Moderate Sedation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Patient Satisfaction
研究概览
简要总结
More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe.
This project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Willing to comply with all study procedures and remain in contact with the study team to complete study assessments for the duration of the study
- •Scheduled for an elective (non-urgent) cardiac catheterization
- •Age of 18 or older at the time of consent
排除标准
- •Adults unable to consent
- •Pregnant women
- •Incarceration
- •Non-English-speaking patients
- •Inability to eat by mouth
- •Patients requiring general anesthesia for cardiac catheterization
- •Inability to fast for at least 6 hours
- •Personal history of pulmonary aspiration, or other known cardiopulmonary anesthetic complication(s)
- •Urgent cardiac catheterization
- •Inability or unwillingness to comply with all study procedures
- •Previously enrolled in this study (patients may not be enrolled more than once for subsequent procedures)
研究组 & 干预措施
Fasting
Prior to the subjects elective cardiac catheterization, they will be instructed to fast for 6 hours with the allowance of clear liquids up to 2 hours.
Non-fasting
Subjects will be instructed to continue to eat and drink according to their normal diet without restriction, prior to their cardiac catheterization.
干预措施: Pre-operative instructions to eat and drink at liberty (Procedure)
结局指标
主要结局
Patient Satisfaction
时间窗: Immediate pre-procedure period, not more than four hours before procedure start-time.
Six-point ordinal scale response preoperative fasting questionnaire. Self-reported.
Pulmonary aspiration/pneumonitis/pneumonia
时间窗: From procedure start time to 48 hours post-procedure.
Indicated by an acute change in oxygen requirement noted in the procedure note or post-procedure progress note. Assessed by chart review. Present/absent.
次要结局
未报告次要终点