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. 2021 Apr 22;2021(4):CD013170. doi: 10.1002/14651858.CD013170.pub2

NCT01518439.

Study name Instrumental and manual Increase of couch[sic] in neuromuscular patients (OPTICOUGH)
Methods Open monocentric randomised cross‐over study
Participants People with NMD with cough inefficiency in a stable respiratory state on recruitment
Interventions Mechanical insufflation: Alpha 200 inspiratory capacity increased with a constant pressure device: Alpha 200 (presume mechanical insufflation)
Mechanical insufflation + physiotherapy: Alpha 200 combined with physiotherapy – inspiratory capacity is increased with the use of constant pressure device (Alpha 200) combined with the manual pressures techniques to increase cough by the physiotherapist (presume mechanical insufflation + MAC)
MI‐E: CoughAssist – increased inspiratory capacity and mechanical exsufflation with the use of insufflation‐exsufflation device (Cough Assist)
MI‐E + MAC: CoughAssist + physiotherapy – increased inspiratory capacity and mechanical exsufflation with the use of insufflation‐exsufflation device (Cough Assist) + the "manual pressures techniques" (presume MAC) to increase cough by the physiotherapist (MI‐E + MAC)
MAC: physiotherapist manual pressures techniques to increase cough applied by the physiotherapist (presumed MAC alone)
Outcomes Primary outcome measures
  • Cough flow obtained from the combination of mechanical and manual cough assistance techniques (presume PCF)


Secondary outcome measures
  • Duration of efficient PCF (> 180 L/min) for each cough assistance technique

  • Respiratory comfort (VAS)

  • Subjective evaluation of cough efficiency (VAS)

  • Respiratory comfort (Borg dyspnoea scale)

Starting date January 2012
Contact information Contact: Helene Prigent, helene.prigent@rpc.aphp.fr
Contact: Sandra Pottier, sandra.pottier@rpc.aphp.fr
Principal investigator: Helene Prigent, MD, PhD
Subinvestigator: Frederic Lofaso, MD, PhD
Subinvestigator: David Orlikowski, MD, PhD
Notes Attempts to contact the corresponding investigators were unsuccessful.