Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial
| Autor: | Jean-Luc Soubirou, Pauline Hacquard, Camille Parent, Felicie Barthomeuf, Lionel Bouvet, Philip Robinson, Marc Lilot, Thomas Tran, Vincent Piriou, Amandine Bellon, Olivia Vassal, Jean-Jacques Lehot, Bruno Baffeleuf, Marine Gueugnon, M.C. Laplace |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Cardiac output medicine.medical_specialty Cardiac index Health Informatics Context (language use) Critical Care and Intensive Care Medicine law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Fluid therapy 030202 anesthesiology law Software Design Anesthesiology Monitoring Intraoperative Abdomen Clinical endpoint medicine Humans Prospective Studies Cardiac Output Aged business.industry Hemodynamic Monitoring 030208 emergency & critical care medicine Middle Aged Anesthesiology and Pain Medicine Elective Surgical Procedures Anesthesia Therapy Computer-Assisted Fluid Therapy Female business Algorithms Abdominal surgery |
| Zdroj: | Journal of clinical monitoring and computing. 32(6) |
| ISSN: | 1573-2614 |
| Popis: | An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min-1 m-2, p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013. |
| Databáze: | OpenAIRE |
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