Focused Cardiac Ultrasound in Surgery

N/ATerminatedNCT03501927

Aarhus University Hospital337 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

337

Conditions

Cardiopulmonary Disease Surgery Morality Complication

Interventions

FOCUS (focused cardiac ultrasound)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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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. -

Locations (1)

Department of Anaesthesiology

Randers, Denmark

Outcomes

Primary Outcomes

Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days

Time frame: 30 days after surgery

Secondary Outcomes

Length of stay

Defined as the number of days admitted to hospital from the date of surgery (included)

Time frame: Up to 180 days after surgery

Re-admissions to hospital

Re-admissions to hospital (no) within 90 days (no)

Time frame: Up to 90 days after surgery

Length of stay

Length of stay including re-admissions to hospital within 90 days

Time frame: Up to 90 days after surgery

Death ≤ 30 days & ≤ 90 days

Death ≤ 30 days \& ≤ 90 days (no)

Time frame: Up to 90 days after surgery

Intensive care treatment

Intensive care treatment (hours)

Time frame: Up to 90 days after surgery

Postoperative ventilator treatment

Postoperative ventilator treatment (hours)

Time frame: Up to 90 days after surgery

Admittance to the post-operative care unit

Admittance to the post-operative care unit (hours)

Time frame: Up to 1 day after surgery

Development of acute kidney injury

Development of acute kidney injury (AKI) (stage 1,2 \& 3, defined by th KDIGO creatinine criteria within seven days of surgery)

Data from ClinicalTrials.gov

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Time frame: Within 7 days of surgery

Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs.

Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs (mg).

Time frame: From start of anaesthesia til end of anaesthesia

Accumulated fluid balance

Accumulated fluid balance until end of surgery

Time frame: From start of anaesthesia til end of anaesthesia

Echocardiography

Formal echocardiography's (1) ordered and (2) actually performed in total and secondarily due to preoperative FOCUS (no).

Time frame: From anaeshetic visit to start of anaesthesia

Surgery cancellations due to preoperative FOCUS

Surgery cancellations in total and secondarily due to preoperative FOCUS (no)

Time frame: Before start of anaeshesia

Surgery postponements due to preoperative FOCUS

Surgery postponements in total and secondarily due to preoperative FOCUS (no).

Time frame: Within 7 days of preoperative anaesthetic visit

Surgery changes

Surgery changes in total and secondarily due to preoperative FOCUS (no, type).

Time frame: From FOCUS to the start of surgery

Perioperative myocardial damage

Troponin I

Time frame: From the day before surgery to the day following surgery

Changes in anesthetic practice

Changes in anesthetic practice/perianesthetic care DUE to preoperative FOCUS. Includes both step up/step down

Time frame: From start of anaesthesia to start of surgery

Echocardiography

Formal echocardiographies ordered prior to surgery

Time frame: From FOCUS to start of surgery

Volume

Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS

Time frame: From FOCUS to the start of anaesthesia

Anaesthesia type

Conversion of Anaesthesia type from primary anesthetic visit to actually performed. Both in total and facilitated by FOCUS.

Time frame: From FOCUS to the start of anaesthesia

Anaesthetic monitoring

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

Time frame: From start of anaesthesia to end of anaesthesia

Anesthesia time

Time frame: From start of anaesthesia to end of anaesthesia

Surgery time

Time frame: From start of surgery to end of surgery

Cardiogenic pulmonary oedema

Cardiogenic pulmonary oedema within 30 days of surgery