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Use of thermal blanket in cochlear implant surgeries: a randomized case-control study to evaluate the incidence of intraoperative hypothermia

Grant number: 24/01538-9
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Start date: April 01, 2024
End date: March 31, 2025
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Luiz Fernando Manzoni Lourencone
Grantee:Rafael Vasconcelos Silva Ferrazini
Host Institution: Hospital de Reabilitação de Anomalias Craniofaciais (HRAC). Universidade de São Paulo (USP). Bauru , SP, Brazil

Abstract

Intraoperative hypothermia, characterized by body temperature below 36 °C, is a common problem in surgeries with general anesthesia, associated with risks for the patient. The use of an active forced-air heating system, such as thermal blankets, is recommended to prevent hypothermia. However, there is no consensus on its effectiveness in cochlear implant surgeries, which present possible complications. Limited studies suggest the need for prospective investigation of the use of these devices in this patient population. The main objective of this study is to compare the incidence of intraoperative hypothermia in patients undergoing cochlear implant surgery using thermal blankets on versus thermal blankets off. Secondary objectives include describing the clinical characteristics of patients who developed hypothermia, evaluating differences in body temperature during surgery, investigating whether the use of the turned-on thermal blanket is associated with an increase in intraoperative body temperature, and reporting any adverse events observed during the study. This is a prospective, observational, longitudinal, randomized and controlled study. Patients will be randomly selected and divided into two groups: one with the use of a thermal blanket on and the other with the thermal blanket initially turned off. The sample will consist of adult and pediatric patients, and the estimated minimum size is 20 patients in each group. During surgery, body temperature will be monitored and recorded every 15 minutes. Other data to be collected include clinical characteristics of patients, characterization of anesthesia, surgery and environment. The study will be conducted in accordance with ethical considerations, including obtaining consent and approval from the Research Ethics Committee. The results aim to provide relevant information about the effectiveness of using thermal blankets in preventing hypothermia in cochlear implant surgeries, contributing to improving safety and clinical results in these patients.

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