The effects of preoperative point-of-care focused cardiac ultrasound in high-risk patients: study protocol for a prospective randomised controlled trial
Jan Pallesen, Rajesh Bhavsar, Jesper Fjølner, Jan Krog, Laima Malachauskiené, Skule Arnesen Bakke, Mikkel Andreas Strømgaard Andersen, Marianne Lauridsen Vang, Jakob Keller Andersen, Michael Helbo Bøndergaard, Thomas Damgaard Jessing, Carsten Thee, Lone Mortensen, Michael Bugge Nielsen, Peter Juhl-Olsen, Jan Pallesen, Rajesh Bhavsar, Jesper Fjølner, Jan Krog, Laima Malachauskiené, Skule Arnesen Bakke, Mikkel Andreas Strømgaard Andersen, Marianne Lauridsen Vang, Jakob Keller Andersen, Michael Helbo Bøndergaard, Thomas Damgaard Jessing, Carsten Thee, Lone Mortensen, Michael Bugge Nielsen, Peter Juhl-Olsen
Abstract
Introduction: Perioperative mortality and morbidity remain substantial in acute surgery. Risk factors include known cardiovascular disease, but preoperative screening is insensitive to occult cardiopulmonary conditions. Focused cardiac ultrasound (FOCUS) can disclose both structural and functional cardiac disease and provides insight into the patient's haemodynamic status. This study aims to clarify whether preoperative FOCUS changes clinical outcomes in high-risk patients.
Methods: This is a multi-centre, randomised, controlled, prospective study including patients ≥ 65 years of age scheduled for acute/emergency abdominal- or orthopaedic surgery. A total of 800 patients will be randomised to ± application of preoperative FOCUS. The primary endpoint is the proportion of patients admitted to hospital > 10 days or death within 30 days of surgery. The secondary endpoints include changes in the anaesthesia approach facilitated by FOCUS, biomarkers of organ function and perioperative complications.
Conclusions: The knowledge generated from this study may facilitate changes in the anaesthesia evaluation and decision process and, consequently, in the entire perioperative anaesthesia clinical practice. The study has the potential to reduce the risk of perioperative cardiopulmonary complications which directly implies improved patient outcome and reduced hospital costs.
Funding: The Research Fund of the Department of Anaesthesiology, Randers Regional Hospital, The Central Denmark Region's Medical Research Fund and the Hospital of Southern Jutland.
Trial registration: NCT03501927.
Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
Source: PubMed