• Neurocritical care · Apr 2021

    Clinical Trial

    Efficacy and Safety of a Nasopharyngeal Catheter for Selective Brain Cooling in Patients with Traumatic Brain Injury: A Prospective, Non-randomized Pilot Study.

    • Raphael Einsfeld Simões Ferreira, Bernardo Lembo Conde de Paiva, de FreitasFlávio Geraldo RezendeFGRDepartamento de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, São Paulo, Brazil., Flávia Ribeiro Machado, Gisele Sampaio Silva, Rafael Mônaco Raposo, Conrado Feisthauer Silveira, and Ricardo Silva Centeno.
    • Departamento de Neurologia e Neurocirurgia, Universidade Federal de São Paulo, Av. Moema 170, Cj. 83. Moema, São Paulo, SP, 04077-020, Brazil. rferreira@unifesp.br.
    • Neurocrit Care. 2021 Apr 1; 34 (2): 581592581-592.

    BackgroundThe efficacy objective was to determine whether a novel nasopharyngeal catheter could be used to cool the human brain after traumatic brain injury, and the safety objective was to assess the local and systemic effects of this therapeutic strategy.MethodsThis was a prospective, non-randomized, interventional clinical trial that involved five patients with severe traumatic brain injury. The intervention consisted of inducing and maintaining selective brain cooling for 24 h by positioning a catheter in the nasopharynx and circulating cold water inside the catheter in a closed-loop arrangement. Core temperature was maintained at ≥ 35 °C using counter-warming.ResultsIn all study participants, a brain temperature reduction of ≥ 2 °C was achieved. The mean brain temperature reduction from baseline was 2.5 ± 0.9 °C (P = .04, 95% confidence interval). The mean systemic temperature was 37.3 ± 1.1 °C at baseline and 36.0 ± 0.8 °C during the intervention. The mean difference between the brain temperature and the systemic temperature during intervention was - 1.2 ± 0.8 °C (P = .04). The intervention was well tolerated with no significant changes observed in the hemodynamic parameters. No relevant variations in intracranial pressure and transcranial Doppler were observed. The laboratory results underwent no major changes, aside from the K+ levels and blood counts. The K+ levels significantly varied (P = .04); however, the variation was within the normal range. Only one patient experienced an event of mild localized and superficial nasal discoloration, which was re-evaluated on the seventh day and indicated complete recovery.ConclusionThe results suggest that our noninvasive method for selective brain cooling, using a novel nasopharyngeal catheter, was effective and safe for use in humans.

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