Focused Cardiac Ultrasound in Surgery (PreOPFOCUS)

Aarhus University Hospital

Status: Terminated

Conditions: Complication; Morality; Surgery; Cardiopulmonary Disease

Treatments: Diagnostic Test: FOCUS (focused cardiac ultrasound)

Study type: Interventional

Funder types: Other

Identifiers

NCT03501927

PreOPFOCUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 337 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 2 patient groups

FOCUS (focused cardiac ultrasound)

Active Comparator group

Description:

Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation.

Treatment:

Diagnostic Test: FOCUS (focused cardiac ultrasound)

Control

No Intervention group

Description:

Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards.