ECHONOF III trial - participants with isolated, primary and non metastatic NOF

Intervention

Intervention code Diagnosis / Prognosis

The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol. The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right ve .... The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol. The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right ventricles' size and function, significant cardiac valve abnormalities (stenosis and regurgitation), presence of pericardial effusion and indirect signs of diastolic left ventricle dysfunction. A written report will be available to the anaesthetist performing the pre-operative assessment and the medical team involved in the patient care (orthopaedics, ortho- geriatricians and general medicine physicians). The intervention is delivered in a single time-point (before surgery); therefore, strategies to monitor adherence are not required.
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Comparison

Control group Active

A standard pre-operative assessment performed by the anaesthetist, which does not include focused transthoracic echocardiography. This assessment takes around 10 to 15 minutes and involves recollection of the medical history, vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) and physical examination.

Outcomes

Outcome: A composite outcome of the incidence of all-cause mortality, hospital readmission, acute kidney injury, decompensated cardiac failure and myocardial injury in non-cardiac surgery (MINS). Data will be collected from patient medical records. Measurement of the levels of troponin for the diagnosis of MINS is outside the standard of care and is considered "an investigative test" that will be organised by the research team and collected at baseline, day 1 and day 2 post sur .... Outcome: A composite outcome of the incidence of all-cause mortality, hospital readmission, acute kidney injury, decompensated cardiac failure and myocardial injury in non-cardiac surgery (MINS). Data will be collected from patient medical records. Measurement of the levels of troponin for the diagnosis of MINS is outside the standard of care and is considered "an investigative test" that will be organised by the research team and collected at baseline, day 1 and day 2 post surgery. Re-admission to the hospital will be collected from the hospital operating system. All-cause mortality: dichotomous data (yes or not). Death of any cause. Hospital readmission: dichotomous data (yes or not) of readmission to hospital for any cause. Acute kidney injury:serum creatinine increase of 1.5-1.9 times from the baseline value in 7 days, or 2 times from baseline value in 1 day or 3 times in 12 hours. Decompensated cardiac failure: Documented new or worsening symptoms due to heart failure including ONE of the following: dyspnoea, decreased exercise tolerance or fatigue AND Objective evidence of new or worsening heart failure consisting in TWO physical examination findings OR ONE physical examination and ONE laboratory criterion. Physical examination: peripheral oedema, OR pulmonary rales/crackles/crepitations, OR increased jugular venous pressure, OR S3 gallop, OR clinically significant or rapid weight gain thought to be related to fluid retention OR increasing ascites in the absence of primary hepatic disease. Laboratory findings: BNP greater than 500 pg/mL or NT-proBNP greater than 2000 pg/ml. OR Radiological evidence of pulmonary congestion. OR Non-invasive diagnostic evidence (E/e’ greater than 15 or plethoric inferior vena cava or decreased ventricular outflow tract minute stroke decreased left ventricular outflow tract (LVOT) minute stroke distance (time velocity integral (TVI)) OR Invasive diagnostic evidence with right heart catheterization showing a pulmonary capillary wedge pressure (pulmonary artery occlusion pressure) greater or equal to 18 mmHg, central venous pressure greater or equal to 12 mmHg, or a cardiac index less or equal to 2.2 L/min/m2 MINS: Trop greater than 20 ng/L and increase of at least 5 ng/L from the preoperative value, or greater than 65 ng/L regardless the preoperative value.
Timepoint: 30 day post-surgery
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