Focused Cardiac Ultrasound in Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Pre-operative Point-of-Care Focused Cardiac Ultrasound on Patient Outcome - a Prospective, Randomized, Clinical Study (PreOPFOCUS)

Conditions
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Cardiopulmonary Disease, Surgery, Morality, Complication

Intervention / Treatment
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* Diagnostic Test: FOCUS (focused cardiac ultrasound)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Preoperative point-of-care focused cardiopulmonary ultrasound (FOCUS) Patients are to be randomised in a 1:1 ratio to either 1) FOCUS prior to anaesthesia or 2) no FOCUS performed (standard treatment).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOCUS (focused cardiac ultrasound)<br>Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation. | Diagnostic Test: FOCUS (focused cardiac ultrasound)<br>* A ultrasound of the heart and pleura will be performed. This provide information on Left ventricular systolic function Left ventricular diastolic function Right ventricular systolic function Right ventricular pressure overload Biventricular sizes Pathology of the mitral- and aortic valves Pericardial fluid Gross fluid status Pleural effusion<br>|
| No Intervention: Control<br>Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Defined as the number of days admitted to hospital from the date of surgery (included) | Up to 180 days after surgery | 
| Re-admissions to hospital | Re-admissions to hospital (no) within 90 days (no) | Up to 90 days after surgery | 
| Length of stay | Length of stay including re-admissions to hospital within 90 days | Up to 90 days after surgery | 
| Death ≤ 30 days & ≤ 90 days | Death ≤ 30 days & ≤ 90 days (no) | Up to 90 days after surgery | 
| Intensive care treatment | Intensive care treatment (hours) | Up to 90 days after surgery | 
| Postoperative ventilator treatment | Postoperative ventilator treatment (hours) | Up to 90 days after surgery | 
| Admittance to the post-operative care unit | Admittance to the post-operative care unit (hours) | Up to 1 day after surgery | 
| Development of acute kidney injury | Development of acute kidney injury (AKI) (stage 1,2 & 3, defined by th KDIGO creatinine criteria within seven days of surgery) | Within 7 days of surgery | 
| Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs. | Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs (mg). | From start of anaesthesia til end of anaesthesia | 
| Accumulated fluid balance | Accumulated fluid balance until end of surgery | From start of anaesthesia til end of anaesthesia | 
| Echocardiography | Formal echocardiography's (1) ordered and (2) actually performed in total and secondarily due to preoperative FOCUS (no). | From anaeshetic visit to start of anaesthesia | 
| Surgery cancellations due to preoperative FOCUS | Surgery cancellations in total and secondarily due to preoperative FOCUS (no) | Before start of anaeshesia | 
| Surgery postponements due to preoperative FOCUS | Surgery postponements in total and secondarily due to preoperative FOCUS (no). | Within 7 days of preoperative anaesthetic visit | 
| Surgery changes | Surgery changes in total and secondarily due to preoperative FOCUS (no, type). | From FOCUS to the start of surgery | 
| Perioperative myocardial damage | Troponin I | From the day before surgery to the day following surgery | 
| Changes in anesthetic practice | Changes in anesthetic practice/perianesthetic care DUE to preoperative FOCUS. Includes both step up/step down | From start of anaesthesia to start of surgery | 
| Echocardiography | Formal echocardiographies ordered prior to surgery | From FOCUS to start of surgery | 
| Volume | Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS | From FOCUS to the start of anaesthesia | 
| Anaesthesia type | Conversion of Anaesthesia type from primary anesthetic visit to actually performed. Both in total and facilitated by FOCUS. | From FOCUS to the start of anaesthesia | 
| Anaesthetic monitoring | 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 | From start of anaesthesia to end of anaesthesia | 
| Anesthesia time | Anesthesia time | From start of anaesthesia to end of anaesthesia | 
| Surgery time | Surgery time | From start of surgery to end of surgery | 
| Cardiogenic pulmonary oedema | Cardiogenic pulmonary oedema within 30 days of surgery | From start of anaesthesia to 30 days after surgery | 
| New onset cardiac arrhythmia | New onset cardiac arrhythmia of any kind. | From start of anaesthesia to 30 days after surgery | 
| Non-fatal cardiac arrest | Non-fatal cardiac arrest regardless of cause. | From start of anaesthesia to 30 days after surgery | 
| Anastomotic breakdown | Anastomotic breakdown (deep or superficial) | From start of anaesthesia to 30 days after surgery | 
| Myocardial infarction | Myocardial infarction as defined by the universal criteria | From start of anaesthesia to 30 days after surgery | 
| Stroke | Cerebral stroke | From start of anaesthesia to 30 days after surgery | 
| Pulmonary embolism | Pulmonary embolism with radiological confirmation | From start of anaesthesia to 30 days after surgery | 
| Postoperative haemorrhage | Postoperative haemorrhage demanding blood transfusion | From end of anaesthesia to 30 days after surgery | 
| Gastrointestinal bleed | Gastrointestinal bleed | From start of anaesthesia to 30 days after surgery | 
| Pneumonia | Pneumonia | From start of anaesthesia to 30 days after surgery | 
| Surgical site infection | Surgical site infection (superficial or deep) | From end of anaesthesia to 30 days after surgery | 
| Urinary tract infection | Urinary tract infection | From end of anaesthesia to 30 days after surgery | 
| Infektion, source unknown | Infektion, source unknown. | From end of anaesthesia to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, FOCUS, Surgery, Anesthesia