Focused Cardiac Ultrasound in Surgery (PreOPFOCUS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Complication; Morality; Cardiopulmonary Disease
• Intervention / Treatment: Diagnostic test: FOCUS (focused cardiac ultrasound)

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.

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Randers, Denmark
    • Department of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FOCUS (focused cardiac ultrasound); Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation.	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
No Intervention: Control; Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Defined as the number of days admitted to hospital from the date of surgery (included)	Up to 180 days after surgery
Re-admissions to hospital	Re-admissions to hospital (no) within 90 days (no)	Up to 90 days after surgery
Length of stay	Length of stay including re-admissions to hospital within 90 days	Up to 90 days after surgery
Death ≤ 30 days & ≤ 90 days	Death ≤ 30 days & ≤ 90 days (no)	Up to 90 days after surgery
Intensive care treatment	Intensive care treatment (hours)	Up to 90 days after surgery
Postoperative ventilator treatment	Postoperative ventilator treatment (hours)	Up to 90 days after surgery
Admittance to the post-operative care unit	Admittance to the post-operative care unit (hours)	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)	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).	From start of anaesthesia til end of anaesthesia
Accumulated fluid balance	Accumulated fluid balance until end of surgery	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).	From anaeshetic visit to start of anaesthesia
Surgery cancellations due to preoperative FOCUS	Surgery cancellations in total and secondarily due to preoperative FOCUS (no)	Before start of anaeshesia
Surgery postponements due to preoperative FOCUS	Surgery postponements in total and secondarily due to preoperative FOCUS (no).	Within 7 days of preoperative anaesthetic visit
Surgery changes	Surgery changes in total and secondarily due to preoperative FOCUS (no, type).	From FOCUS to the start of surgery
Perioperative myocardial damage	Troponin I	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	From start of anaesthesia to start of surgery
Echocardiography	Formal echocardiographies ordered prior to surgery	From FOCUS to start of surgery
Volume	Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS	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.	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	From start of anaesthesia to end of anaesthesia
Anesthesia time	Anesthesia time	From start of anaesthesia to end of anaesthesia
Surgery time	Surgery time	From start of surgery to end of surgery
Cardiogenic pulmonary oedema	Cardiogenic pulmonary oedema within 30 days of surgery	From start of anaesthesia to 30 days after surgery
New onset cardiac arrhythmia	New onset cardiac arrhythmia of any kind.	From start of anaesthesia to 30 days after surgery
Non-fatal cardiac arrest	Non-fatal cardiac arrest regardless of cause.	From start of anaesthesia to 30 days after surgery
Anastomotic breakdown	Anastomotic breakdown (deep or superficial)	From start of anaesthesia to 30 days after surgery
Myocardial infarction	Myocardial infarction as defined by the universal criteria	From start of anaesthesia to 30 days after surgery
Stroke	Cerebral stroke	From start of anaesthesia to 30 days after surgery
Pulmonary embolism	Pulmonary embolism with radiological confirmation	From start of anaesthesia to 30 days after surgery
Postoperative haemorrhage	Postoperative haemorrhage demanding blood transfusion	From end of anaesthesia to 30 days after surgery
Gastrointestinal bleed	Gastrointestinal bleed	From start of anaesthesia to 30 days after surgery
Pneumonia	Pneumonia	From start of anaesthesia to 30 days after surgery
Surgical site infection	Surgical site infection (superficial or deep)	From end of anaesthesia to 30 days after surgery
Urinary tract infection	Urinary tract infection	From end of anaesthesia to 30 days after surgery
Infektion, source unknown	Infektion, source unknown.	From end of anaesthesia to 30 days after surgery

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Randers Regional Hospital; Aabenraa Hospital
• Investigators: Principal Investigator: Jan Pallesen, MD, Randers Regional Hospital; Principal Investigator: Rajesh Bhavsar, MD, Aabenraa Hospital

Publications and helpful links

General Publications

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• Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
• M Saklad. Grading patients for surgical procedures. Anesthesiology 1941;2:281-4
• Davenport DL, Ferraris VA, Hosokawa P, Henderson WG, Khuri SF, Mentzer RM Jr. Multivariable predictors of postoperative cardiac adverse events after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg. 2007 Jun;204(6):1199-210. doi: 10.1016/j.jamcollsurg.2007.02.065.
• Kheterpal S, O'Reilly M, Englesbe MJ, Rosenberg AL, Shanks AM, Zhang L, Rothman ED, Campbell DA, Tremper KK. Preoperative and intraoperative predictors of cardiac adverse events after general, vascular, and urological surgery. Anesthesiology. 2009 Jan;110(1):58-66. doi: 10.1097/ALN.0b013e318190b6dc.
• Asch FM, Shah S, Rattin C, Swaminathan S, Fuisz A, Lindsay J. Lack of sensitivity of the electrocardiogram for detection of old myocardial infarction: a cardiac magnetic resonance imaging study. Am Heart J. 2006 Oct;152(4):742-8. doi: 10.1016/j.ahj.2006.02.037.
• Olive KE, Grassman ED. Mitral valve prolapse: comparison of diagnosis by physical examination and echocardiography. South Med J. 1990 Nov;83(11):1266-9. doi: 10.1097/00007611-199011000-00008.
• Beyerbacht HP, Bax JJ, Lamb HJ, van der Laarse A, Vliegen HW, de Roos A, Zwinderman AH, van der Wall EE. Evaluation of ECG criteria for left ventricular hypertrophy before and after aortic valve replacement using magnetic resonance imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):465-74. doi: 10.1081/jcmr-120022262.
• Holm JH, Frederiksen CA, Juhl-Olsen P, Sloth E. Perioperative use of focus assessed transthoracic echocardiography (FATE). Anesth Analg. 2012 Nov;115(5):1029-32. doi: 10.1213/ANE.0b013e31826dd867. Epub 2012 Oct 9. No abstract available.
• Botker MT, Vang ML, Grofte T, Sloth E, Frederiksen CA. Routine pre-operative focused ultrasonography by anesthesiologists in patients undergoing urgent surgical procedures. Acta Anaesthesiol Scand. 2014 Aug;58(7):807-14. doi: 10.1111/aas.12343. Epub 2014 May 28.
• Kratz T, Campo Dell'Orto M, Exner M, Timmesfeld N, Zoremba M, Wulf H, Steinfeldt T. Focused intraoperative transthoracic echocardiography by anesthesiologists: a feasibility study. Minerva Anestesiol. 2015 May;81(5):490-6. Epub 2014 Sep 15.
• Cowie B. Focused transthoracic echocardiography predicts perioperative cardiovascular morbidity. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):989-93. doi: 10.1053/j.jvca.2012.06.031. Epub 2012 Aug 22.
• Kratz T, Steinfeldt T, Exner M, Dell Orto MC, Timmesfeld N, Kratz C, Skrodzki M, Wulf H, Zoremba M. Impact of Focused Intraoperative Transthoracic Echocardiography by Anesthesiologists on Management in Hemodynamically Unstable High-Risk Noncardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):602-609. doi: 10.1053/j.jvca.2016.11.002. Epub 2016 Nov 2.
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• Balik M, Plasil P, Waldauf P, Pazout J, Fric M, Otahal M, Pachl J. Ultrasound estimation of volume of pleural fluid in mechanically ventilated patients. Intensive Care Med. 2006 Feb;32(2):318. doi: 10.1007/s00134-005-0024-2. Epub 2006 Jan 24.
• Pallesen J, Bhavsar R, Fjolner J, Krog J, Malachauskiene L, Bakke SA, Andersen MAS, Vang ML, Andersen JK, Bondergaard MH, Jessing TD, Thee C, Mortensen L, Nielsen MB, Juhl-Olsen P. The effects of preoperative point-of-care focused cardiac ultrasound in high-risk patients: study protocol for a prospective randomised controlled trial. Dan Med J. 2020 Jan;67(1):A07190410.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Surgery; Anesthesia; FOCUS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: PreOPFOCUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Protocol and statistical plan will be published in a peer-reviewed journal. Study results will be made available at a freely accessible online site.
• IPD Sharing Time Frame: Protocol within 6 months of study commencement Study results within 6 months of study termination
• IPD Sharing Access Criteria: Public
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No