Focused Cardiac Ultrasound in Surgery

Surgery Clinical Trial

— PreOPFOCUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03501927
• Other study ID #: PreOPFOCUS
• Status: Terminated
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: April 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 337
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Complication
• Morality
• Pulmonary Heart Disease
• Surgery

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology	Randers

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aabenraa Hospital, Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (26)

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Bøtker MT, Vang ML, Grøfte 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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients admitted to hospital = 10 days or dead within 30 days		30 days after surgery
Secondary	Length of stay	Defined as the number of days admitted to hospital from the date of surgery (included)	Up to 180 days after surgery
Secondary	Re-admissions to hospital	Re-admissions to hospital (no) within 90 days (no)	Up to 90 days after surgery
Secondary	Length of stay	Length of stay including re-admissions to hospital within 90 days	Up to 90 days after surgery
Secondary	Death = 30 days & = 90 days	Death = 30 days & = 90 days (no)	Up to 90 days after surgery
Secondary	Intensive care treatment	Intensive care treatment (hours)	Up to 90 days after surgery
Secondary	Postoperative ventilator treatment	Postoperative ventilator treatment (hours)	Up to 90 days after surgery
Secondary	Admittance to the post-operative care unit	Admittance to the post-operative care unit (hours)	Up to 1 day after surgery
Secondary	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
Secondary	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
Secondary	Accumulated fluid balance	Accumulated fluid balance until end of surgery	From start of anaesthesia til end of anaesthesia
Secondary	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
Secondary	Surgery cancellations due to preoperative FOCUS	Surgery cancellations in total and secondarily due to preoperative FOCUS (no)	Before start of anaeshesia
Secondary	Surgery postponements due to preoperative FOCUS	Surgery postponements in total and secondarily due to preoperative FOCUS (no).	Within 7 days of preoperative anaesthetic visit
Secondary	Surgery changes	Surgery changes in total and secondarily due to preoperative FOCUS (no, type).	From FOCUS to the start of surgery
Secondary	Perioperative myocardial damage	Troponin I	From the day before surgery to the day following surgery
Secondary	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
Secondary	Echocardiography	Formal echocardiographies ordered prior to surgery	From FOCUS to start of surgery
Secondary	Volume	Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS	From FOCUS to the start of anaesthesia
Secondary	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
Secondary	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
Secondary	Anesthesia time	Anesthesia time	From start of anaesthesia to end of anaesthesia
Secondary	Surgery time	Surgery time	From start of surgery to end of surgery
Secondary	Cardiogenic pulmonary oedema	Cardiogenic pulmonary oedema within 30 days of surgery	From start of anaesthesia to 30 days after surgery
Secondary	New onset cardiac arrhythmia	New onset cardiac arrhythmia of any kind.	From start of anaesthesia to 30 days after surgery
Secondary	Non-fatal cardiac arrest	Non-fatal cardiac arrest regardless of cause.	From start of anaesthesia to 30 days after surgery
Secondary	Anastomotic breakdown	Anastomotic breakdown (deep or superficial)	From start of anaesthesia to 30 days after surgery
Secondary	Myocardial infarction	Myocardial infarction as defined by the universal criteria	From start of anaesthesia to 30 days after surgery
Secondary	Stroke	Cerebral stroke	From start of anaesthesia to 30 days after surgery
Secondary	Pulmonary embolism	Pulmonary embolism with radiological confirmation	From start of anaesthesia to 30 days after surgery
Secondary	Postoperative haemorrhage	Postoperative haemorrhage demanding blood transfusion	From end of anaesthesia to 30 days after surgery
Secondary	Gastrointestinal bleed	Gastrointestinal bleed	From start of anaesthesia to 30 days after surgery
Secondary	Pneumonia	Pneumonia	From start of anaesthesia to 30 days after surgery
Secondary	Surgical site infection	Surgical site infection (superficial or deep)	From end of anaesthesia to 30 days after surgery
Secondary	Urinary tract infection	Urinary tract infection	From end of anaesthesia to 30 days after surgery
Secondary	Infektion, source unknown	Infektion, source unknown.	From end of anaesthesia to 30 days after surgery