Focused Cardiac Ultrasound in Surgery
- Conditions
- SurgeryCardiopulmonary DiseaseMoralityComplication
- Interventions
- Diagnostic Test: FOCUS (focused cardiac ultrasound)
- Registration Number
- NCT03501927
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 337
- 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 4.
- Age ≥ 65 years
- 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. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOCUS (focused cardiac ultrasound) FOCUS (focused cardiac ultrasound) Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation.
- Primary Outcome Measures
Name Time Method Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days 30 days after surgery
- Secondary Outcome Measures
Name Time Method Re-admissions to hospital Up to 90 days after surgery Re-admissions to hospital (no) within 90 days (no)
Intensive care treatment Up to 90 days after surgery Intensive care treatment (hours)
Postoperative ventilator treatment Up to 90 days after surgery Postoperative ventilator treatment (hours)
Development of acute kidney injury Within 7 days of surgery Development of acute kidney injury (AKI) (stage 1,2 \& 3, defined by th KDIGO creatinine criteria within seven days of surgery)
Volume From FOCUS to the start of anaesthesia Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS
Stroke From start of anaesthesia to 30 days after surgery Cerebral stroke
Perioperative myocardial damage From the day before surgery to the day following surgery Troponin I
Death ≤ 30 days & ≤ 90 days Up to 90 days after surgery Death ≤ 30 days \& ≤ 90 days (no)
Admittance to the post-operative care unit Up to 1 day after surgery Admittance to the post-operative care unit (hours)
Surgery cancellations due to preoperative FOCUS Before start of anaeshesia Surgery cancellations in total and secondarily due to preoperative FOCUS (no)
Changes in anesthetic practice From start of anaesthesia to start of surgery Changes in anesthetic practice/perianesthetic care DUE to preoperative FOCUS. Includes both step up/step down
Anastomotic breakdown From start of anaesthesia to 30 days after surgery Anastomotic breakdown (deep or superficial)
Echocardiography From FOCUS to start of surgery Formal echocardiographies ordered prior to surgery
Anaesthesia type From FOCUS to the start of anaesthesia Conversion of Anaesthesia type from primary anesthetic visit to actually performed. Both in total and facilitated by FOCUS.
Myocardial infarction From start of anaesthesia to 30 days after surgery Myocardial infarction as defined by the universal criteria
New onset cardiac arrhythmia From start of anaesthesia to 30 days after surgery New onset cardiac arrhythmia of any kind.
Length of stay Up to 90 days after surgery Length of stay including re-admissions to hospital within 90 days
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 intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs (mg).
Accumulated fluid balance From start of anaesthesia til end of anaesthesia Accumulated fluid balance until end of surgery
Surgery postponements due to preoperative FOCUS Within 7 days of preoperative anaesthetic visit Surgery postponements in total and secondarily due to preoperative FOCUS (no).
Surgery changes From FOCUS to the start of surgery Surgery changes in total and secondarily due to preoperative FOCUS (no, type).
Anaesthetic monitoring From start of anaesthesia to end of anaesthesia Step up and step down in anesthetic monitoring. Both in total and facilitated by FOCUS. Includes extra intravenous lines inserted including central venous catheters, arterial lines inserted, change to 5-lead ECG, vasopressors infused with anaesthetic induction
Anesthesia time From start of anaesthesia to end of anaesthesia Anesthesia time
Surgery time From start of surgery to end of surgery Surgery time
Cardiogenic pulmonary oedema From start of anaesthesia to 30 days after surgery Cardiogenic pulmonary oedema within 30 days of surgery
Postoperative haemorrhage From end of anaesthesia to 30 days after surgery Postoperative haemorrhage demanding blood transfusion
Infektion, source unknown From end of anaesthesia to 30 days after surgery Infektion, source unknown.
Non-fatal cardiac arrest From start of anaesthesia to 30 days after surgery Non-fatal cardiac arrest regardless of cause.
Pulmonary embolism From start of anaesthesia to 30 days after surgery Pulmonary embolism with radiological confirmation
Gastrointestinal bleed From start of anaesthesia to 30 days after surgery Gastrointestinal bleed
Surgical site infection From end of anaesthesia to 30 days after surgery Surgical site infection (superficial or deep)
Urinary tract infection From end of anaesthesia to 30 days after surgery Urinary tract infection
Pneumonia From start of anaesthesia to 30 days after surgery Pneumonia
Trial Locations
- Locations (1)
Department of Anaesthesiology
🇩🇰Randers, Denmark