Do Patients Need Pre-Procedural Fasting for Coronary Artery Procedures?
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 主要终点
- Primary: Reduction in the incidence of vasovagal complications.
研究概览
简要总结
Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.
The investigators aim to assess if there is a reduced incidence of vasovagal complications (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR, participant satisfaction if participants are not kept fasting.
This (pilot) randomised control trial will have an intervention arm allowing participants to drink clear liquids freely up to 1 hour before the procedure versus keeping them traditionally NPO.
240 patients will be randomised with 120 participants in each arm.
详细描述
Introduction, background and justification for the study
Patients are traditionally kept Nulla-Per-Os/Nil-By-Mouth (NPO/NBM) for 4-6 hours prior to cardiac procedures including: diagnostic coronary angiograms, right heart catheters, percutaneous coronary interventions and device therapies to minimize the risk of vomiting and pulmonary aspiration during sedation or general anesthesia. The risk of developing pulmonary aspiration is 0.0015 % following emergency coronary artery bypass (CABG) surgery in patients without pre-procedural fasting. There is currently no data available regarding the risk of aspiration during cardiac angiographic interventions, but the risk is likely lower than that of emergency CABG. Currently no North-American or European guidelines require patients to be fasted before cardiac procedures.
The incidence of emergency CABG following cardiac catheterization is between 0.15 % to 0.4 %, whilst that of cardiac arrest is about 1%. In the subset of patients who develop cardiac arrest during elective cardiac catheterization or PCI, the incidence of pulmonary aspiration is low and similar between survivors and non-survivors (8.9% of patients who developed cardiac arrest).
Unsurprisingly, patients admitted with acute MI undergoing Primary PCI (PPCI) are not fasted beforehand and the need for emergency intubation/CABG remains rare in these patients.
A study has shown a rare occurrence of pulmonary aspiration in general anesthesia with a risk of 0.02% for elective and 0.1% for emergency procedures. In two randomized controlled trials, no case of pulmonary aspiration was reported despite the absence of pre-procedure fasting and use of Midazolam/Diazepam/etomidate.
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
- Single (Investigator)
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
- •Ability to give written informed consent
- •Diagnostic coronary angiography and coronary interventions (both elective and stable Acute Coronary Syndrome {ACS} patients).
- •≥ 18 years of age
排除标准
- •Patients who are intubated
- •Patients unable to give informed consent
- •Patients presenting with an acute unstable condition, including:
- •unstable ACS
- •Patients with a history of or at risk for aspiration pneumonia
- •dysphagia
- •severe gastroesophageal reflux disease
- •Patients with known or anticipated difficult airway
- •Patients who request to be allotted to a particular arm of the study
- •Patients who are temporary transfers from other hospitals
结局指标
主要结局
Primary: Reduction in the incidence of vasovagal complications.
时间窗: 1 day
The presence of two or more of the following during the cardiac invasive procedure or during sheath removal or while manual pressure is being applied to the site will constitute a positive vasovagal reaction : i) Reduced level of consciousness, nausea and vomiting, and cold, clammy, pale skin ii) Reduction in blood pressure to \< 100mmHg systolic or \> 15% decrease from baseline iii) Reduction in the heart rate to \< 60 beats/minute (or if initial heart rate is \< 60/minute, a decrease of \> 15% from baseline). Patients' heart rate and blood pressure will be monitored (continuously) intra-procedure and (every 15 minutes) post-procedure during sheath removal and while manual pressure is being applied. The expected rate of vasovagal reaction in the NPO group is 3% .
次要结局
- Secondary: 1. Patient satisfaction with procedure as assessed by the patient satisfaction survey form.(1 day)
- Secondary: 2. Overall incidence of aspiration pneumonia (intra and post-procedural).(1 week post procedure)
- Secondary: 4. Post-procedure change eGFR (∆eGFR) compared to pre-procedure.(5 days post procedure)
- Secondary: 5. Volume of gastric content immediately prior to the cardiac intervention(1 day)
- Secondary: 3. Post-procedure change serum creatinine (∆creatinine) compared to pre-procedure.(5 days post procedure)