Focused Cardiac Ultrasound in Surgery

NCT ID: NCT03501927

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2020-09-01

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.

Conditions

Cardiopulmonary Disease; Surgery; Morality; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FOCUS (focused cardiac ultrasound)

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

Group Type: ACTIVE_COMPARATOR

FOCUS (focused cardiac ultrasound)

Intervention Type: DIAGNOSTIC_TEST

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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. -

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Randers Regional Hospital

OTHER

Sponsor Role: collaborator

Aabenraa Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan Pallesen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Pallesen, MD

Role: PRINCIPAL_INVESTIGATOR

Randers Regional Hospital

Rajesh Bhavsar, MD

Role: PRINCIPAL_INVESTIGATOR

Aabenraa Hospital

Locations

Department of Anaesthesiology

Randers, , Denmark

Countries

Denmark

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Other Identifiers

PreOPFOCUS

Identifier Type: -

Identifier Source: org_study_id