Cardiopulmonary Disease, Complication, Morality, Surgery
Conditions
Keywords
Ultrasound, FOCUS, Surgery, Anesthesia
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.
Interventions
DIAGNOSTIC_TESTFOCUS (focused cardiac ultrasound)
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
Sponsors
Randers Regional Hospital
Aabenraa Hospital
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days | 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-admissions to hospital | Up to 90 days after surgery | Re-admissions to hospital (no) within 90 days (no) |
| Death ≤ 30 days & ≤ 90 days | Up to 90 days after surgery | Death ≤ 30 days & ≤ 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) |
| Admittance to the post-operative care unit | Up to 1 day after surgery | Admittance to the post-operative care unit (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) |
| 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 |
| Echocardiography | From anaeshetic visit to start of anaesthesia | Formal echocardiography's (1) ordered and (2) actually performed in total and secondarily due to preoperative FOCUS (no). |
| Surgery cancellations due to preoperative FOCUS | Before start of anaeshesia | Surgery cancellations in total and secondarily due to preoperative FOCUS (no) |
| 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). |
| Perioperative myocardial damage | From the day before surgery to the day following surgery | Troponin I |
| 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 |
| Volume | From FOCUS to the start of anaesthesia | Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS |
| 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. |
| Length of stay | Up to 180 days after surgery | Defined as the number of days admitted to hospital from the date of surgery (included) |
| 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 |
| New onset cardiac arrhythmia | From start of anaesthesia to 30 days after surgery | New onset cardiac arrhythmia of any kind. |
| Non-fatal cardiac arrest | From start of anaesthesia to 30 days after surgery | Non-fatal cardiac arrest regardless of cause. |
| Anastomotic breakdown | From start of anaesthesia to 30 days after surgery | Anastomotic breakdown (deep or superficial) |
| Myocardial infarction | From start of anaesthesia to 30 days after surgery | Myocardial infarction as defined by the universal criteria |
| Stroke | From start of anaesthesia to 30 days after surgery | Cerebral stroke |
| Pulmonary embolism | From start of anaesthesia to 30 days after surgery | Pulmonary embolism with radiological confirmation |
| Postoperative haemorrhage | From end of anaesthesia to 30 days after surgery | Postoperative haemorrhage demanding blood transfusion |
| Gastrointestinal bleed | From start of anaesthesia to 30 days after surgery | Gastrointestinal bleed |
| Pneumonia | From start of anaesthesia to 30 days after surgery | Pneumonia |
| 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 |
| Infektion, source unknown | From end of anaesthesia to 30 days after surgery | Infektion, source unknown. |
| 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 |
Countries
Denmark
Outcome results
None listed