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

Abstract 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 n...

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Main Authors: Daniela de Almeida Souza, Marina Wolff Branco, Hipólito Carraro Junior, Ana Márcia Delattre Zocolotti, Sibele Yoko Mattozo Takeda, Silvia Valderramas
Format: Article
Language:English
Published: BMC 2023-05-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07362-5
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author Daniela de Almeida Souza
Marina Wolff Branco
Hipólito Carraro Junior
Ana Márcia Delattre Zocolotti
Sibele Yoko Mattozo Takeda
Silvia Valderramas
author_facet Daniela de Almeida Souza
Marina Wolff Branco
Hipólito Carraro Junior
Ana Márcia Delattre Zocolotti
Sibele Yoko Mattozo Takeda
Silvia Valderramas
author_sort Daniela de Almeida Souza
collection DOAJ
description Abstract 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.
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spelling doaj.art-b6b9a1d166e348729ee12c66ee369fc92023-05-28T11:27:00ZengBMCTrials1745-62152023-05-0124111010.1186/s13063-023-07362-5Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trialDaniela de Almeida Souza0Marina Wolff Branco1Hipólito Carraro Junior2Ana Márcia Delattre Zocolotti3Sibele Yoko Mattozo Takeda4Silvia Valderramas5Internal Medicine and Health Sciences, Universidade Federal Do ParanaInternal Medicine and Health Sciences, Universidade Federal Do ParanaIntensive Care Unit, Complexo Hospital de ClinicasDepartment of Prevention and Rehabilitation in Physiotherapy of the Universidade Federal Do ParanaDepartment of Prevention and Rehabilitation in Physiotherapy of the Universidade Federal Do ParanaInternal Medicine and Health Sciences and Department of Prevention and Rehabilitation in Physical Therapy, Universidade Federal Do ParanaAbstract 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.https://doi.org/10.1186/s13063-023-07362-5Mechanical ventilatorsStrokeIntracranial pressureRespiratory mechanicsPhysical therapy techniquesRandomized controlled trial
spellingShingle Daniela de Almeida Souza
Marina Wolff Branco
Hipólito Carraro Junior
Ana Márcia Delattre Zocolotti
Sibele Yoko Mattozo Takeda
Silvia Valderramas
Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
Trials
Mechanical ventilators
Stroke
Intracranial pressure
Respiratory mechanics
Physical therapy techniques
Randomized controlled trial
title Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
title_full Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
title_fullStr Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
title_full_unstemmed Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
title_short Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial
title_sort mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients protocol for a randomized controlled equivalence trial
topic Mechanical ventilators
Stroke
Intracranial pressure
Respiratory mechanics
Physical therapy techniques
Randomized controlled trial
url https://doi.org/10.1186/s13063-023-07362-5
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