Mechanical Hyperinflation Maneuver and intracranial pressure of critical neurological patients: protocol for a randomized clinical trial.

Abstract Background: Mechanical Hyperinflation Maneuver (MHM) is a technique known for optimizing bronchial hygiene and respiratory mechanics, however its effects on intracranial pressure are not known. Methods: 48 patients aged ≥ 18 years, with clinical diagnosis of acute stroke, confirmed by neuroimaging examination, with onset of symptoms within 72 hours, under mechanical ventilation through tracheal tube, will participate in this study. Participants will be randomly allocated into 2 groups: Experimental Group (n=24): MHM plus tracheal aspiration, and Control Group (n=24): tracheal aspiration only. Intracranial pressure will be measured by a non-invasive technique using Brain4care BcMM-R-2000 sensor. This will be the primary outcome. Results will be recorded at 5 times: T0 (start of monitoring), T1 (moment before MHM), T2 (moment after the MHM and before tracheal aspiration), T3 (moment after tracheal aspiration), T4 and T5 (monitoring 10 and 20 minutes after T3). Secondary outcomes are respiratory mechanics and hemodynamic parameters. Discussion: This study will be the first clinical trial to examine the effects and safety of MHM on intracranial pressure measured by non-invasive monitoring. Limitation includes the impossibility of blinding the physical therapist who will supervise the interventions. It is expected with this study to demonstrate that MHM can improve respiratory mechanics and hemodynamic parameters, and provide a safe intervention with no changes in intracranial pressure in stroke patients.Trial registration: Brazilian Clinical Trial Registry (RBR – 5qs9k2n). Registered on 27 July 2021. https://ensaiosclinicos.gov.br/rg/RBR-5qs9k2nProtocol version 1.0, protocol date March, 2019.