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Randomized Controlled Trial Comparative Study
Automated closed-loop versus manually controlled norepinephrine infusion in patients undergoing intermediate- to high-risk abdominal surgery: a randomised controlled trial.
- Alexandre Joosten, Dragos Chirnoaga, Philippe Van der Linden, Luc Barvais, Brenton Alexander, Jacques Duranteau, Jean-Louis Vincent, Maxime Cannesson, and Joseph Rinehart.
- Department of Anaesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium; Department of Anaesthesiology and Intensive Care, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Université Paris-Saclay, Hôpital De Bicêtre, Assistance Publique Hôpitaux de Paris, Le Kremlin-Bicêtre, France. Electronic address: Alexandre.Joosten@erasme.ulb.ac.be.
- Br J Anaesth. 2021 Jan 1; 126 (1): 210218210-218.
BackgroundHypotension occurs frequently during surgery and may be associated with adverse complications. Vasopressor titration is frequently used to correct hypotension, but requires considerable time and attention, potentially reducing the time available for other clinical duties. To overcome this issue, we have developed a closed-loop vasopressor (CLV) controller to help correct hypotension more efficiently. The aim of this randomised controlled study was to evaluate whether the CLV controller was superior to traditional vasopressor management at minimising hypotension in patients undergoing abdominal surgery.MethodsThirty patients scheduled for elective intermediate-to high-risk abdominal surgery were randomised into two groups. In the CLV group, hypotension was corrected automatically via the CLV controller system, which adjusted the rate of a norepinephrine infusion according to MAP values recorded using an advanced haemodynamic device. In the control group, management of hypotension consisted of standard, manual adjustment of the norepinephrine infusion. The primary outcome was the percentage of time that a patient was hypotensive, defined as MAP <90% of their baseline value, during surgery.ResultsThe percentage of time patients were hypotensive during surgery was 10 times less in the CVL group than in the control group (1.6 [0.9-2.3]% vs 15.4 [9.9-24.3]%; difference: 13 [95% confidence interval: 9-19]; P<0.0001). The CVL group also spent much less time with MAP <65 mm Hg (0.2 [0.0-0.4]% vs 4.5 [1.1-7.9]%; P<0.0001).ConclusionsIn patients undergoing intermediate- to high-risk surgery under general anaesthesia, computer-assisted adjustment of norepinephrine infusion significantly decreases the incidence of hypotension compared with manual control.Clinical Trial RegistrationNCT04089644.Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
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