Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial.

BACKGROUND: Mechanical hyperinflation maneuver (MHM) is a technique known for optimizing bronchial hygiene and respiratory mechanics; however, its effects on intracranial compliance are not known. METHODS: Sixty patients aged ≥ 18 years, with clinical diagnosis of acute stroke, confirmed by neuroimaging examination, with onset of symptoms within 72 h, under mechanical ventilation through tracheal tube, will participate in this study. Participants will be randomly allocated into 2 groups: experimental group (n = 30)-MHM plus tracheal aspiration-and control group (n = 30)-tracheal aspiration only. Intracranial compliance 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 min 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 compliance 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 compliance in stroke patients.