Efficacy of using a mechanical insufflation-exsufflation versus manual respiratory physiotherapy on cough peak flow in hospitalised older adults in French hospitals: a protocol for a single-blind randomised clinical trial.

INTRODUCTION

Ageing impairs the respiratory system, increasing hospitalisation rates for respiratory problems in older adults. In cases of bronchial congestion, a weak cough in older inpatients challenges respiratory physiotherapy. Mechanical insufflation-exsufflation (MI-E) is one of the promising solutions. However, its effects have not yet been evaluated in this population. Therefore, we aim to compare the effects of MI-E and manual respiratory physiotherapy on cough peak flow (CPF), spirometry measures, dyspnoea and session discomfort in hospitalised older adults.

METHODS AND ANALYSIS: We will conduct a multicentre randomised controlled trial in four hospitals in France. A total of 120 older inpatients with bronchial congestion and a weak cough will be recruited from either intensive care units or conventional wards. All participants will receive three sessions of respiratory physiotherapy over one and a half days: MI-E for the experimental group and conventional manual respiratory therapy for the control group. Assessments will include CPF, forced vital capacity (FVC), maximum inspiratory and expiratory pressures, forced expiratory volume in one second (FEV1), FEV1/FVC ratio and the modified Borg scale for dyspnoea, measured before and immediately after each session. Discomfort will be assessed using a numerical (0-10) scale immediately after each session. Between-group comparisons will be performed using a linear mixed model for continuous outcomes and a generalised linear model for categorical variables.

ETHICS AND DISSEMINATION: The study was approved by the referred ethics committee (Comité de Protection des Personnes Ile de France XI, Identifier: 24.04832.000282) on 27 November 2024. Study results will be disseminated in peer-reviewed publications and at scientific meetings.

TRIAL REGISTRATION NUMBER: NCT06730217.