NCT03501927

Focused Cardiac Ultrasound in Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiopulmonary Disease
• Surgery
• Morality
• Complication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FOCUS (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

Timeline

• Start date: 2018-05-07
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-04-18
• Last updated: 2021-04-30

Locations

1 site across 1 country: Denmark