A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients
Background: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-08-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/12/9/1409 |
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| author | Yann Gricourt Camille Prin Derre Christophe Demattei Sébastien Bertran Benjamin Louart Laurent Muller Natacha Simon Jean-Yves Lefrant Philippe Cuvillon Samir Jaber Claire Roger |
| author_facet | Yann Gricourt Camille Prin Derre Christophe Demattei Sébastien Bertran Benjamin Louart Laurent Muller Natacha Simon Jean-Yves Lefrant Philippe Cuvillon Samir Jaber Claire Roger |
| author_sort | Yann Gricourt |
| collection | DOAJ |
| description | Background: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (SIMON method). Each FC (250 mL saline solution for 10 min) proposed by the CL was systematically validated by the anaesthesiologist who could either confirm or refuse the FC or give FC without the CL system. A ≥ 95% agreement between the CL and the anaesthesiologist was considered acceptable. Results: The study was interrupted after interim analysis of the first 19 patients (10 men, median age = 61 years, median body mass index = 26 kg/m<sup>2</sup>). The anaesthesiologists accepted 165/205 (80%) of fluid boluses proposed by the CL. Median cardiac index (CI) was 2.9 (interquartile: IQ (2.7; 3.4) L/min/m<sup>2</sup>) and the median coefficient of variation (CV) for CI was 13% (10; 17). Fifteen out of nineteen patients (79%) had a mean CI > 2.5 L/min/m<sup>2</sup> or spent > 85% surgery time with pulse pressure variation < 13%. No adverse events related to the CL were reported. Conclusion: In this study of patients scheduled for elective major abdominal surgery, the agreement between CL and anaesthesiologist for giving fluid challenge was 80%, suggesting that CL cannot replace the physician but could help in decision making. |
| first_indexed | 2024-03-09T23:29:27Z |
| format | Article |
| id | doaj.art-a2a68e981ff84181816f4303665d8371 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-09T23:29:27Z |
| publishDate | 2022-08-01 |
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| record_format | Article |
| series | Journal of Personalized Medicine |
| spelling | doaj.art-a2a68e981ff84181816f4303665d83712023-11-23T17:12:39ZengMDPI AGJournal of Personalized Medicine2075-44262022-08-01129140910.3390/jpm12091409A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery PatientsYann Gricourt0Camille Prin Derre1Christophe Demattei2Sébastien Bertran3Benjamin Louart4Laurent Muller5Natacha Simon6Jean-Yves Lefrant7Philippe Cuvillon8Samir Jaber9Claire Roger10IMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceLaboratoire de Biostatistique, Epidémiologie Clinique, Santé Publique Innovation et Méthodologie (BESPIM), Pôle Pharmacie, Santé Publique, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceDépartement d’Anesthésie Réanimation B St Eloi Hospital, 80 Avenue Augustin Fliche, 34295 Montpellier, FranceIMAGINE, UR-UM 107, University of Montpellier, Division of Anaesthesia Critical Care, Pain and Emergency Medicine, Nîmes University Hospital, 30900 Nîmes, FranceBackground: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (SIMON method). Each FC (250 mL saline solution for 10 min) proposed by the CL was systematically validated by the anaesthesiologist who could either confirm or refuse the FC or give FC without the CL system. A ≥ 95% agreement between the CL and the anaesthesiologist was considered acceptable. Results: The study was interrupted after interim analysis of the first 19 patients (10 men, median age = 61 years, median body mass index = 26 kg/m<sup>2</sup>). The anaesthesiologists accepted 165/205 (80%) of fluid boluses proposed by the CL. Median cardiac index (CI) was 2.9 (interquartile: IQ (2.7; 3.4) L/min/m<sup>2</sup>) and the median coefficient of variation (CV) for CI was 13% (10; 17). Fifteen out of nineteen patients (79%) had a mean CI > 2.5 L/min/m<sup>2</sup> or spent > 85% surgery time with pulse pressure variation < 13%. No adverse events related to the CL were reported. Conclusion: In this study of patients scheduled for elective major abdominal surgery, the agreement between CL and anaesthesiologist for giving fluid challenge was 80%, suggesting that CL cannot replace the physician but could help in decision making.https://www.mdpi.com/2075-4426/12/9/1409high-risk surgeryintraoperative fluid optimisationclosed-loop |
| spellingShingle | Yann Gricourt Camille Prin Derre Christophe Demattei Sébastien Bertran Benjamin Louart Laurent Muller Natacha Simon Jean-Yves Lefrant Philippe Cuvillon Samir Jaber Claire Roger A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients Journal of Personalized Medicine high-risk surgery intraoperative fluid optimisation closed-loop |
| title | A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients |
| title_full | A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients |
| title_fullStr | A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients |
| title_full_unstemmed | A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients |
| title_short | A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients |
| title_sort | pilot study assessing a closed loop system for goal directed fluid therapy in abdominal surgery patients |
| topic | high-risk surgery intraoperative fluid optimisation closed-loop |
| url | https://www.mdpi.com/2075-4426/12/9/1409 |
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