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ACTIVE NOT RECRUITING
NCT03355105
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2019-03-07

Completion Date

2024-12-24

Last Updated

2024-06-11

Healthy Volunteers

No

Interventions

OTHER

Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort

The exsufflation pressures will be progressively increased starting from -20 cmH2O with 10 cmH2O increments up. 3 coughing operations will be realised for each level, until obtention of 10% of AUC decrease or a PCF collapse of at least 10% over the last 2 levels and without exceeding -70 cmH2O. The selected landing will be the one allowing the largest PCF without presence of collapse. An intermediate bearing between 2 bearings may be tested in order to approach an optimum adjustment threshold less than 5 cmH2O.

OTHER

Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort

The exsufflation pressures will be gradually increased from -20 cmH2O, with 10 cmH2O increments up to a maximum of -70 cmH2O. The selected level will be the one selected both by the patient and the "clinician" therapist and considered as making it possible to obtain the most effective cough according to the return of the patient.

Locations (1)

Department of Physiology and Functional Explorations, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France