Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients (EXSUFLOW)

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    50
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 23 April 2022
weakness
cough

Summary

In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. The use of cough assistance is therefore essential in order to avoid acute situations such as bronchial superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique commonly used by therapists in a hospital or at the patient's home in order to facilitate the airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point because it conditions the effectiveness of the generated cough. It'is important to take into account the presence of any collapse in the use of IM / E in order to ensure the most effective cough given by the patient. Actually, except the common impression of the physiotherapist and the patient, there is no "simple" way for detecting and objectifying the threshold of collapse in the upper airways.

The aim of this study is to compare two modalities for the regulation of the level of the MI-E exsufflation, taking into account the presence of a collapse: a subjective "S" adjustment based on the clinical judgment of the therapist and the patient and an objective "O" adjustment based on the flow-volume curve generated during the cough.

Description

This is a bicentric, prospective crossover, randomized, open label trial. The study will focus on 50 adult patients with stable neuromuscular conditions, outside the congestion period requiring cough help.

Patients will be recruited from among the neuromuscular disease patients followed for their respiratory management in the home ventilation unit of the Raymond Poincaré Hospital Intensive care Unit or in the Aincourt Neurological Rehabilitation Service attached to the Vexin Intercommunal Hospital Group.

The cough help performed with the MI / E will be evaluated according to two conditions of adjustment of the exsufflation pressure: a subjective adjustment (modality S) and an objective adjustment (modality O), whose order will be randomized to control a phenomenon of tiredness causing confusion.

A respiratory technician and two therapists will participate to the protocol. The therapist "clinician" and "evaluator" role will be defined by a draw.

The protocol will take place during the same day of hospitalization in two stages:

  • T0: validation of the eligibility criteria and inclusion of patients in the study.
  • T1: evaluation of coughing performance according to the two modes of exsufflation pressure adjustment. Adjustment modality "S" according to the clinical impression of the "clinician" therapist and the patient, and the "Cough Peak Expiratory Flow" measured by the MI / E. Adjustment modality "O": according to the analysis of the flow / volume curve measured using a spirometer and a pneumotachograph.

Details
Condition Neuromuscular Diseases
Treatment Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort, Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort
Clinical Study IdentifierNCT03355105
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged ≥18 years
Neuromuscular pathology
Coughing aid information: DEPT <180 l / min
In stable condition and without bulk
Good understanding and cognition to follow the instructions and to inform the EVA
Affiliated to a Sickness Insurance Plan or entitled
Signed of informed consent

Exclusion Criteria

Pregnant woman
Person under guardianship
Inability to cooperate and / or communicate
Acute decompensated organ
Patient with following contraindications to mechanical in-exsufflation (MI-E) devices
pneumothorax
pneumomediastinum
pulmonary emphysema
hemoptysis
pleurisy
nausea
obstructive pulmonary disease or asthma
recent lobectomy of the lung
intracranial pressure
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