The 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.
This 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.
In 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.
The 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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The authors are grateful for the assistance of Prof. Dr. Feres Chaddad, head of the of neurosurgery department at the Universidade Federal de São Paulo, and also for his guidance during this research. We are also immensely grateful to Fabio Lacreta, Murilo Barbosa, and Ronaldo Escudeiro for their assistance with equipment and with the patients’ records. It is with gratitude that we acknowledge their contributions. A contract research organization (EUROTRIALS™, Lisbon, Portugal) was responsible for monitoring, data management, statistical analysis, and preparation of all study reports. The authors would also like to thank all study participants and their families and all the multidisciplinary team of the emergency department and intensive care unit of the São Paulo Hospital.
This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brasil (CAPES)—Finance Code 001.
Conflict of interest
Dr. Einsfeld Simões Ferreira and Dr. Lembo Conde de Paiva received grants from Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brasil (CAPES) during the conduct of the study. In addition, Dr. Einsfeld Simões Ferreira and Dr. Lembo Conde de Paiva have a patented catheter system and method for target body temperature management licensed to Floe Ind Com e Importação de equipamentos. Bernardo Paiva and Raphael Einsfeld are founders of the company which developed the investigational device.
The study protocol and associated documents were submitted to the Institutional Review Board of the Federal University of São Paulo, and the study protocol was approved by the Institutional Review Board.
Written informed consent was obtained from all patients.
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Ferreira, R.E.S., de Paiva, B.L.C., de Freitas, F.G.R. et al. Efficacy and Safety of a Nasopharyngeal Catheter for Selective Brain Cooling in Patients with Traumatic Brain Injury: A Prospective, Non-randomized Pilot Study. Neurocrit Care 34, 581–592 (2021). https://doi.org/10.1007/s12028-020-01052-9