Clinical trial NCT03501927: Focused Cardiac Ultrasound in Surgery
Official title: The Effects of Pre-operative Point-of-Care Focused Cardiac Ultrasound on Patient Outcome - a Prospective, Randomized, Clinical Study (PreOPFOCUS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiopulmonary Disease
Surgery
Morality
Complication
Keywords: Ultrasound
FOCUS
Surgery
Anesthesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
name: Aabenraa Hospital
First posted: 2018-04-18
Enrollment: 337
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preoperative point-of-care focused cardiopulmonary ultrasound (FOCUS) Patients are to be randomised in a 1:1 ratio to either 1) FOCUS prior to anaesthesia or 2) no FOCUS performed (standard treatment).
Primary purpose: PREVENTION

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.

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. -

Primary outcomes:
measure: Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Length of stay
timeFrame: Up to 180 days after surgery
measure: Re-admissions to hospital
timeFrame: Up to 90 days after surgery
measure: Length of stay
timeFrame: Up to 90 days after surgery
measure: Death ≤ 30 days & ≤ 90 days
timeFrame: Up to 90 days after surgery
measure: Intensive care treatment
timeFrame: Up to 90 days after surgery
measure: Postoperative ventilator treatment
timeFrame: Up to 90 days after surgery
measure: Admittance to the post-operative care unit
timeFrame: Up to 1 day after surgery
measure: Development of acute kidney injury
timeFrame: Within 7 days of surgery
measure: Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs.
timeFrame: From start of anaesthesia til end of anaesthesia
measure: Accumulated fluid balance
timeFrame: From start of anaesthesia til end of anaesthesia
measure: Echocardiography
timeFrame: From anaeshetic visit to start of anaesthesia
measure: Surgery cancellations due to preoperative FOCUS
timeFrame: Before start of anaeshesia
measure: Surgery postponements due to preoperative FOCUS
timeFrame: Within 7 days of preoperative anaesthetic visit
measure: Surgery changes
timeFrame: From FOCUS to the start of surgery
measure: Perioperative myocardial damage
timeFrame: From the day before surgery to the day following surgery
measure: Changes in anesthetic practice
timeFrame: From start of anaesthesia to start of surgery
measure: Echocardiography
timeFrame: From FOCUS to start of surgery
measure: Volume
timeFrame: From FOCUS to the start of anaesthesia
measure: Anaesthesia type
timeFrame: From FOCUS to the start of anaesthesia
measure: Anaesthetic monitoring
timeFrame: From start of anaesthesia to end of anaesthesia
measure: Anesthesia time
timeFrame: From start of anaesthesia to end of anaesthesia
measure: Surgery time
timeFrame: From start of surgery to end of surgery
measure: Cardiogenic pulmonary oedema
timeFrame: From start of anaesthesia to 30 days after surgery
measure: New onset cardiac arrhythmia
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Non-fatal cardiac arrest
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Anastomotic breakdown
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Myocardial infarction
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Stroke
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Pulmonary embolism
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Postoperative haemorrhage
timeFrame: From end of anaesthesia to 30 days after surgery
measure: Gastrointestinal bleed
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Pneumonia
timeFrame: From start of anaesthesia to 30 days after surgery
measure: Surgical site infection
timeFrame: From end of anaesthesia to 30 days after surgery
measure: Urinary tract infection
timeFrame: From end of anaesthesia to 30 days after surgery
measure: Infektion, source unknown
timeFrame: From end of anaesthesia to 30 days after surgery
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Department of Anaesthesiology
Study officials:
affiliation: Randers Regional Hospital
name: Jan Pallesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aabenraa Hospital
name: Rajesh Bhavsar, MD
role: PRINCIPAL_INVESTIGATOR
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