Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial - 05/07/24
the EMOCAR Study Group
Abstract |
Background |
Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO2) 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 rSO2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO2 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 rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
Trial registration |
ClinicalTrials.gov identifier: NCT01415648.
El texto completo de este artículo está disponible en PDF.Keywords : Near-infrared spectroscopy, Regional cerebral oxygen saturation, Carotid endarterectomy
Esquema
Vol 43 - N° 4
Artículo 101388- août 2024 Regresar al número
Artículo precedente
- Preoperative ketamine administration for prevention of postoperative neurocognitive disorders after major orthopedic surgery in elderly patients: A multicenter randomized blinded placebo-controlled trial
- Franck Verdonk, Pierre Lambert, Clément Gakuba, Anais Charles Nelson, Thomas Lescot, Fanny Garnier, Jean-Michel Constantin, Danielle Saurel, Sigismond Lasocki, Emmanuel Rineau, Pierre Diemunsch, Lucas Dreyfuss, Benoît Tavernier, Lucillia Bezu, Julien Josserand, Alexandre Mebazaa, Marine Coroir, Karine Nouette-Gaulain, Gerard Macouillard, Pauline Glasman, Denis Lemesle, Vincent Minville, Philippe Cuvillon, Brice Gaudilliere, Christophe Quesnel, Pierre Abdel-Ahad, Tarek Sharshar, Serge Molliex, Raphael Gaillard, Jean Mantz
- Reduction of red blood cell transfusion with a patient blood management protocol in urological and visceral surgery: a before-after study
- A. Godon, M. Dupuis, S. Amdaa, G. Pevet, E. Girard, G. Fiard, D. Sourd, JL. Bosson, JF. Payen, P. Albaladejo, P. Bouzat
Bienvenido a EM-consulte, la referencia de los profesionales de la salud.
El acceso al texto completo de este artículo requiere una suscripción.
¿Ya suscrito a @@106933@@ revista ?