Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial.

Autor: Le Teurnier Y; Centre Hospitalo-Universitaire de Nantes, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Laennec, France., Rozec B; Centre Hospitalo-Universitaire de Nantes, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Laennec, France; CNRS, INSERM, Institut du thorax, Université de Nantes, France., Degryse C; Centre Hospitalo-Universitaire de Bordeaux, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Pellegrin, France., Levy F; Centre Hospitalo-Universitaire de Strasbourg, Service d'Anesthésie Réanimation Chirurgicale, France., Miliani Y; Centre Hospitalo-Universitaire de Marseille, Service d'Anesthésie Réanimation Chirurgicale, Hôpital La Timone, France., Godet G; Centre Hospitalo-Universitaire de Rennes, Service d'Anesthésie Réanimation Chirurgicale, Hôpital de Pontchailloux, France., Daccache G; Centre Hospitalo-Universitaire de Caen, Service d'Anesthésie Réanimation Chirurgicale, France., Truc C; Centre Hospitalo-Universitaire de Lyon, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Edouard Herriot, France., Steinmetz E; Centre Hospitalo-Universitaire de Dijon, Service de Chirurgie Vasculaire, Hôpital Le Bocage, France., Ouattara A; Centre Hospitalo-Universitaire de Bordeaux, Service d'Anesthésie Réanimation Cardiovasculaire, Hôpital Haut Levêque, France., Cholley B; Centre Hospitalo-Universitaire Georges Pompidou, AP-HP, Service d'Anesthésie Réanimation Chirurgicale, France., Malinovsky JM; Centre Hospitalo-Universitaire de Reims, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Robert Debré, France., Portier D; Hôpital Privé du Confluent, Service d'Anesthésie, Nantes, France., Dupont G; Centre Hospitalo-Universitaire de Besançon, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Jean Minjoz, France., Liutkus D; Centre Hospitalier du Mans, Service d'Anesthésie Réanimation Chirurgicale, France., Viard P; Hôpital Privé Marie-Lannelongue, Service d'Anesthésie Réanimation Chirurgicale, Paris, France., Pere M; Plateforme de Méthodologie et Biostatistique, CHU de Nantes, Nantes, France., Daumas-Duport B; Centre Hospitalo-Universitaire de Nantes, Service d'imagerie Médicale, Hôpital Laennec, France., Magras PA; Centre Hospitalo-Universitaire de Nantes, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Laennec, France., Vourc'h M; Centre Hospitalo-Universitaire de Nantes, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Laennec, France; INSERM CIC 0004 Immunologie et infectiologie, Université de Nantes, France. Electronic address: mickael.vourch@chu-nantes.fr.
Jazyk: angličtina
Zdroj: Anaesthesia, critical care & pain medicine [Anaesth Crit Care Pain Med] 2024 Aug; Vol. 43 (4), pp. 101388. Date of Electronic Publication: 2024 May 04.
DOI: 10.1016/j.accpm.2024.101388
Abstrakt: Background: Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO 2 ) monitoring reduces the occurrence of cerebral ischemic lesions is unknown.
Methods: This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO 2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO 2 in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery.
Results: Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (±1.05) in the standard group vs. 0.58 (±2.83), in the NIRS group; mean difference, 0.23 [95% CI, -0.06 to 0.52]; estimate, 0.22 [95% CI, -0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group vs. 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, -0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0-6.0] in the standard group vs. 5.0 [4.0-6.0] in the NIRS group; mean difference, -0.11 [95% CI, -0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) vs. the NIRS group (0.92%); absolute difference = 0.24% [95% CI, -0.94 to 1.41].
Conclusions: Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO 2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
Trial Registration: ClinicalTrials.gov identifier: NCT01415648.
(Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)
Databáze: MEDLINE
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