Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Pre-procedural patient satisfaction and comfort
研究概览
简要总结
The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications.
The study will answer:
- Does eating and drinking before the procedure improve patient comfort?
- Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc?
Participants will be randomly assigned to either:
- A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or
- A no-fasting group (able to eat and drink as usual).
Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.
详细描述
While pre-procedural fasting is a longstanding tradition in cardiac catheterization, there is limited evidence supporting its necessity in low-risk patients undergoing urgent procedures for acute coronary syndromes (ACS). Existing studies have lacked adequate recruitment of ACS patients, comprehensive demographic capture, and long-term outcomes.
This randomized clinical trial will enroll adult inpatients undergoing cardiac catheterization for worsening angina and low risk ACS (unstable angina, and non-high risk NSTEMI's) with planned moderate proceduralist-guided sedation. Participants will be randomized 1:1 to either standard fasting (≥6 hours for solids and ≥2 hours for clear liquids) or no fasting requirement.
The primary endpoint is a composite of patient-reported outcomes assessing comfort and satisfaction. Secondary outcomes focus on clinical safety metrics, such as hemodynamic instability, aspiration pneumonia, ICU admission, procedural sedation requirements, and 30-day mortality, etc.
Proceduralists will remain unblinded; however, outcome assessment and statistical analysis will be performed by blinded third-party personnel. This trial aims to provide high-quality data to assess the necessity and impact of fasting in this specific patient population.
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
- •All scheduled urgent inpatient non-high risk cardiac catheterizations for worsening angina (cardiac chest pain or anginal equivalent), unstable angina, or non-high risk NSTEMI-NSTEMI's with GRACE score <140 points) utilizing proceduralist guided sedation
排除标准
- •* High risk NSTEMI's defined as NSTEMI's with a GRACE score \>140 points
- •* Hemodynamic instability (\6L Nasal Cannula Supplementation, BiPAP, or invasive ventilation
- •* Emergent interventions: STEMI/high risk NSTEMI
- •* Need for mechanical circulatory support-ECMO, Impella or intra-aortic balloon pump
结局指标
主要结局
Pre-procedural patient satisfaction and comfort
时间窗: Within one hour pre-cardiac catheterization
Patient satisfaction and comfort will be assessed using a six-item survey evaluating hunger, thirst, nausea, nervousness, anger, and weakness. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree" = least discomfort) to 5 ("strongly agree" = most discomfort). The total score ranges from 6 (best possible comfort) to 30 (worst possible discomfort). Higher scores indicate greater overall discomfort.
次要结局
- Time since last oral intake(At time of procedure)
- Hypotension(During procedure and up to 6 hours post-procedure)
- Hyperglycemia(During or within 6 hours post-procedure)
- Hypoglycemia(Within 6 hours pre and post-procedure)
- New hypoxic respiratory failure(During or with 6 hours post-procedure, not present prior to catheterization.)
- Aspiration pneumonia(Within 72 hours post-procedure, not present prior to catheterization.)
- New non-invasive or invasive ventilation(During or within 24 hours post-procedure)
- New intensive care unit (ICU) admission(Within 24 hours post-procedure)
- Need for emergency surgical intervention(During or within 24 hours post-procedure)
- 30-day mortality(30 days post-procedure)
- Sedation use(During procedure)
研究者
Samip Vasaiwala
Primary Investigator
University of South Florida