NCT01518439

Brief Summary

Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

January 11, 2012

Last Update Submit

July 18, 2013

Conditions

Neuromuscular DiseaseChronic Respiratory FailureCoughing

Keywords

neuromuscularcoughrestrictive

Outcome Measures

Primary Outcomes (1)

  • cough flow obtained from the combination of mechanical and manual cough assistance techniques

    2 Hours

Secondary Outcomes (4)

  • duration of efficient cough flow (above 180 l/min)under each cough assistance technique

    2 Hours

  • respiratory comfort

    2 Hours

  • subjective evaluation of cough efficiency

    2 Hours

  • Respiratory comfort

    2 Hours

Study Arms (1)

neuromuscular patients

EXPERIMENTAL

neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion

Device: Alpha 200®Device: Alpha 200® + physiotherapistDevice: Cough Assist®Device: Cough Assist® + physiotherapistOther: physiotherapist

Interventions

Alpha 200®DEVICE

inspiratory capacity is increased with the use of constant pressure device: Alpha 200®

neuromuscular patients
Alpha 200® + physiotherapistDEVICE

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

neuromuscular patients
Cough Assist®DEVICE

increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)

neuromuscular patients
Cough Assist® + physiotherapistDEVICE

increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist

neuromuscular patients
physiotherapistOTHER

manual pressures techniques to increase cough applied by the physiotherapist

neuromuscular patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients
  • neuromuscular disorders with a respiratory restrictive syndrome (VC \< 40% and/or cough flow \< 180 L/min and/or Pe max \< 40 cmH2O)
  • non invasive ventilation
  • signed informed consent form

You may not qualify if:

  • unstable respiratory state with increased bronchial secretions
  • unstable hemodynamics
  • pneumothorax and or emphysema
  • tracheostomy
  • major bulbar involvement with swallowing dysfunction with the liquids
  • Persons under Guardianship or Trusteeship
  • Pregnant women
  • not covered by the social security system
  • refusal of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAYMOND POINCARE Hospital

Garches, Garches, 92380, France

Location

Related Publications (1)

  • Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.

    PMID: 33887060DERIVED

MeSH Terms

Conditions

Neuromuscular DiseasesCough

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Nervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Frederic Lofaso, Md-PhD

    University of Versailles

    STUDY DIRECTOR

  • Helene Prigent, MD-PhD

    University of Versailles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 26, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

July 1, 2013

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations

FR(1)