Fasting or Non-fasting Before Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.
研究概览
简要总结
The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures.
Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory).
Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.
详细描述
Nil by mouth (NBM) has been the standard of care for cardiac catheterization since its inception. The associated vomiting was common with the first generation of radiocontrast materials that were almost toxic, and with the use of general anaesthesia. Induction of anaesthesia depresses the cough and swallow reflex, thus increasing the risk of aspiration. This is also true for deep sedation. However, the practice has largely changed nowadays, with cardiac catheterization procedures being done under local anaesthesia with anxiolytic sedatives often used peri-procedurally to achieve minimal sedation whereby verbal contact is maintained. Both the Royal College of Anaesthetists and the Royal College of Emergency Medicine state that fasting is not required for minimal or conscious sedation but does recommend fasting for general anaesthesia. There is only less than a 1% risk of needing emergency surgery for percutaneous coronary interventions (PCIs). The risk of developing pulmonary aspiration following emergency coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in patients without pre-procedural fasting is in the order of 0.001%.
There was no evidence that the volume or pH of participants' gastric contents differ significantly between fasting and non-fasting populations, as shown by Brady et al. In addition, the overall incidence of nausea and vomiting was reported to be 1% before elective cerebral angiography in a study carried out by Kwon et al. with no significant difference between fasting and non-fasting groups.
A recently conducted a retrospective analysis of registry data for 1916 percutaneous coronary intervention (PCI) patients over a 3-year period. None of the patients was kept nil by mouth (NBM) pre-procedure, and no patients required immediate endotracheal intubation, nor did any develop aspiration pneumonia intra or post procedurally. Thus, they concluded in their observational study that patients undergoing PCI do not need to have fasted before their procedures.
The American Society of Anaesthesia guidelines discuss this extensively and have concluded that there is no strong relation between fasting, gastric volume, or risk of aspiration. In any case, the patients at highest risk for nausea and vomiting are those who present with ST-elevation myocardial infarction (STEMI), who are not fasting anyway, and the need for emergency intubation/CABG remains rare in these patients.
Prolonged unnecessary fasting can often leave patients dissatisfied and add to the discomfort and anxiety of waiting for a procedure. Patients may also choose to miss their usual medications on the morning of the procedure due to restrictions advised with oral intake, increasing the risk of complications such as poorly controlled hypertension and the associated peri-procedural 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
- •All patients >18 years undergoing elective coronary angiography or angioplasty procedures in the 2 months window from consent.
排除标准
- •Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention.
- •Emergency primary percutaneous coronary intervention.
- •Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.
时间窗: Within 4 hours after the procedure.
incidence of self-reported nausea measured on a binary scale (yes or no)
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting.
时间窗: Within 4 hours after the procedure.
Incidence of vomiting assessed on binary scale (yes or no).
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia.
时间窗: During the procedure
Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia.
时间窗: Within 2 hours before the procedure.
Incidence of hypoglycemia peri-procedure (blood sugar \< 3.6 mmol/l) as assessed by finger prick test.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension.
时间窗: Within 2 hours before the procedure.
Pre-procedural hypotension (systolic blood pressure \<90 mmHg and /or diastolic blood pressure \< 60 mmHg as measured non-invasively by sphygmomanometer)
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation.
时间窗: During the procedure
Incidence of emergency tracheal intubation for respiratory failure
次要结局
- Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description(Within 4 hours after the procedure)
研究者
Hesham Abdelaziz
Principal Investigator
Blackpool Victoria Hospital