NCT03355105.

Study name	Comparison of two methods of adjusting mechanical in‐exsufflation in neuromuscular adult patients (EXSUFLOW)
Methods	Bicentric, prospective cross‐over, randomised, open‐label trial
Participants	50 adults with stable NMDs
Interventions	Objective adjustment of the MI‐E Pe and evaluation of cough effort: the Pes will be progressively increased starting from –20 cmH2O with 10 cmH2O increments. 3 cough efforts will be performed for each level, until obtaining a 10% of area under the curve decrease or a PCF decline of ≥ 10% over last 2 levels, and without exceeding –70 cmH2O. The selected setting will be the one allowing the largest PCF without presence of collapse. An intermediate bearing between 2 bearings may be tested to approach an optimum adjustment threshold < 5 cmH2O. Subjective adjustment of the MI‐E Pe and evaluation of cough effort: the Pes 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.
Outcomes	Primary outcome AUC flow volume (at baseline). The primary endpoint is the AUC flow volume during the cough expiratory phase. To compare the cough effectiveness obtained according to the current modalities of the MI‐E Pe setting to that resulting from an adjustment based on the analysis of the flow‐volume curve. Secondary outcomes PCF Association between the PCF generated and subjective criteria Subjective therapist cough effectiveness (VAS) Subjective participant cough effectiveness (VAS) Respiratory comfort (VAS)
Starting date	28 November 2017
Contact information	Contact: Frédéric LOFASO, MD, PhD: f.lofaso@aphp.fr Contact: Aurélien BORÉ: kines.widal3@rpc.aphp.fr
Notes	Attempts to contact corresponding authors were unsuccessful.