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

NCT03355105 | Active Not Recruiting

• 2 other identifiers: K160910J2017-A01794-49
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular disease

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC) Flow Volume

  The primary endpoint is the Area Under Curve (AUC) Flow Volume during the cough expiratory phase. To compare the cough effectiveness obtained according to the current modalities of the MI / E exsuflation pressure setting to that resulting from an adjustment based on the analysis of the flow-volume curve.

  At baseline

Secondary Outcomes (5)

• Peak Cough Flow (PCF)

  At baseline

• Evaluate the association between the peak cough flow (PCF) generated and the subjective criteria

  At baseline

• Subjective Therapist Cough Effectiveness

  At baseline

• Subjective Patient Cough Effectiveness

  At baseline

• Respiratory comfort

  At baseline

Study Arms (2)

Objective adjustment of the MI/E exsuflation pressure

EXPERIMENTAL

Objective adjustment of the MI/E exsuflation pressure based on the flow-volume curve generated during the cough.

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

Subjective adjustment of the MI/E exsuflation pressure

ACTIVE COMPARATOR

Subjective adjustment of the MI/E exsuflation pressure based on the clinical judgment of the therapist and the patient.

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

Interventions

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

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.

Objective adjustment of the MI/E exsuflation pressure

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

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.

Subjective adjustment of the MI/E exsuflation pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Physiology and Functional Explorations, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Frédéric LOFASO, MD, PhD

  Department of Physiology and Functional Explorations, Raymond Poincaré Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: March 7, 2019
• Primary Completion: December 23, 2024
• Study Completion: December 24, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)