The Effects of Pre-operative Point-of-Care Focused Cardiac Ultrasound on Patient Outcome - a Prospective, Randomized, Clinical Study (PreOPFOCUS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days
研究概览
简要总结
Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may elucidate pathology and potential hemodynamic compromise unknown to handling physicians. This study aims to investigate the effects of focused cardiac ultrasound in high-risk patients undergoing non-cardiac surgery with respect to clinical endpoints.
详细描述
In non-cardiac surgery major risk factors for morbidity and mortality include ASA classification, age, acute surgery and pre-existing cardiopulmonary disease. These risk factors are sometimes readily available and, along with the type of surgery, allow anaesthesiologists to tailor anaesthetic drugs, fluid therapy and monitoring to the individual patient need. However, cardiopulmonary disease may be occult or masked by other patient-related incapacities. Hence, identification of cardiopulmonary disease is an important priority during the pre-operative anaesthesia evaluation. Routine pre-operative anaesthesia evaluation includes screening with auscultation, blood tests and often electrocardiography. However, these exams are insensitive for detecting cardiopulmonary diseases that may be life threatening during anaesthesia, including ischaemia, heart valve disease and left ventricular hypertrophy.
Point-of-care focused cardiac ultrasound (FOCUS) is claimed to be an effective method for filling out this obvious gap in rapid diagnostic capability, as FOCUS can detect both structural and functional cardiac disease as well as pleural effusion. FOCUS performed by anaesthesiologists can identify unknown pathologies in surgical patients and identification of these enables prediction of perioperative morbidity. Although pre-operative FOCUS has been shown to alter anaesthetic patient management, it remains unclear whether the application of FOCUS actually impacts patient outcome.
This study aims to clarify whether pre-operative FOCUS changes clinical outcomes in high-risk patients undergoing acute, non-cardiac surgery.
The hypothesis of the study is that pre-operative FOCUS reduces the fraction of patients admitted to hospital for more than 10 days or are dead within 30 days after high risk, non-cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for emergency (< 6 hours) or urgent surgery (< 24 hours)15
- •General or neuro-axial anaesthesia planned at the first anesthetic visit
- •ASA classification 3 or
- •Age ≥ 65 years
排除标准
- •Previous surgery performed during current hospital admission (including transfers from other hospitals than Randers Regional Hospital/Hospital of Southern Jutland)
- •Low risk surgery or expected surgery time < 30 minutes or endoscopies.
- •Lack of consent from patient or proxy (in case of patient mental incapacity)
- •Previous participation in the study. Pre-operative FOCUS not possible for logistical reasons or due to requirement for immediate surgery
- •Drop-out Criteria:
- •Patients who refuse participation after formal inclusion will drop out.
- •Patients converted from a primary anaesthetic plan of general/neuro-axial anaesthesia to regional anaesthesia will not drop-out. -
结局指标
主要结局
Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days
时间窗: 30 days after surgery
次要结局
- Re-admissions to hospital(Up to 90 days after surgery)
- Intensive care treatment(Up to 90 days after surgery)
- Postoperative ventilator treatment(Up to 90 days after surgery)
- Development of acute kidney injury(Within 7 days of surgery)
- Volume(From FOCUS to the start of anaesthesia)
- Stroke(From start of anaesthesia to 30 days after surgery)
- Perioperative myocardial damage(From the day before surgery to the day following surgery)
- Death ≤ 30 days & ≤ 90 days(Up to 90 days after surgery)
- Admittance to the post-operative care unit(Up to 1 day after surgery)
- Surgery cancellations due to preoperative FOCUS(Before start of anaeshesia)
- Changes in anesthetic practice(From start of anaesthesia to start of surgery)
- Echocardiography(From FOCUS to start of surgery)
- Anaesthesia type(From FOCUS to the start of anaesthesia)
- Myocardial infarction(From start of anaesthesia to 30 days after surgery)
- New onset cardiac arrhythmia(From start of anaesthesia to 30 days after surgery)
- Length of stay(Up to 90 days after surgery)
- Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs.(From start of anaesthesia til end of anaesthesia)
- Accumulated fluid balance(From start of anaesthesia til end of anaesthesia)
- Surgery postponements due to preoperative FOCUS(Within 7 days of preoperative anaesthetic visit)
- Surgery changes(From FOCUS to the start of surgery)
- Anaesthetic monitoring(From start of anaesthesia to end of anaesthesia)
- Anesthesia time(From start of anaesthesia to end of anaesthesia)
- Surgery time(From start of surgery to end of surgery)
- Anastomotic breakdown(From start of anaesthesia to 30 days after surgery)
- Cardiogenic pulmonary oedema(From start of anaesthesia to 30 days after surgery)
- Postoperative haemorrhage(From end of anaesthesia to 30 days after surgery)
- Infektion, source unknown(From end of anaesthesia to 30 days after surgery)
- Non-fatal cardiac arrest(From start of anaesthesia to 30 days after surgery)
- Pulmonary embolism(From start of anaesthesia to 30 days after surgery)
- Gastrointestinal bleed(From start of anaesthesia to 30 days after surgery)
- Surgical site infection(From end of anaesthesia to 30 days after surgery)
- Urinary tract infection(From end of anaesthesia to 30 days after surgery)
- Pneumonia(From start of anaesthesia to 30 days after surgery)
研究者
Jan Pallesen
Principal Investigator
Randers Regional Hospital