Instrumental and Manual Increase of Couch in Neuromuscular Patients (OPTICOUGH)
Primary Purpose
Neuromuscular Disease, Chronic Respiratory Failure, Coughing
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alpha 200®
Alpha 200® + physiotherapist
Cough Assist®
Cough Assist® + physiotherapist
physiotherapist
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Disease focused on measuring neuromuscular, cough, restrictive
Eligibility Criteria
Inclusion Criteria:
- 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
- stable respiratory state > 1 month before inclusion
- signed informed consent form
Exclusion Criteria:
- 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
Sites / Locations
- RAYMOND POINCARE Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neuromuscular patients
Arm Description
neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
Outcomes
Primary Outcome Measures
cough flow obtained from the combination of mechanical and manual cough assistance techniques
Secondary Outcome Measures
duration of efficient cough flow (above 180 l/min)under each cough assistance technique
respiratory comfort
evaluation with a visual analogical scale
subjective evaluation of cough efficiency
evaluation with a visual analogical scale
Respiratory comfort
evaluation with the Borg dyspnea scale
Full Information
NCT ID
NCT01518439
First Posted
January 11, 2012
Last Updated
July 18, 2013
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance
1. Study Identification
Unique Protocol Identification Number
NCT01518439
Brief Title
Instrumental and Manual Increase of Couch in Neuromuscular Patients
Acronym
OPTICOUGH
Official Title
Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Hypothesis: Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions.
Objectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques.
Method:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion.
As this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disease, Chronic Respiratory Failure, Coughing
Keywords
neuromuscular, cough, restrictive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neuromuscular patients
Arm Type
Experimental
Arm Description
neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
Intervention Type
Device
Intervention Name(s)
Alpha 200®
Intervention Description
inspiratory capacity is increased with the use of constant pressure device: Alpha 200®
Intervention Type
Device
Intervention Name(s)
Alpha 200® + physiotherapist
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Cough Assist®
Intervention Description
increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)
Intervention Type
Device
Intervention Name(s)
Cough Assist® + physiotherapist
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
physiotherapist
Intervention Description
manual pressures techniques to increase cough applied by the physiotherapist
Primary Outcome Measure Information:
Title
cough flow obtained from the combination of mechanical and manual cough assistance techniques
Time Frame
2 Hours
Secondary Outcome Measure Information:
Title
duration of efficient cough flow (above 180 l/min)under each cough assistance technique
Time Frame
2 Hours
Title
respiratory comfort
Description
evaluation with a visual analogical scale
Time Frame
2 Hours
Title
subjective evaluation of cough efficiency
Description
evaluation with a visual analogical scale
Time Frame
2 Hours
Title
Respiratory comfort
Description
evaluation with the Borg dyspnea scale
Time Frame
2 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
stable respiratory state > 1 month before inclusion
signed informed consent form
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Lofaso, Md-PhD
Organizational Affiliation
University of Versailles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helene Prigent, MD-PhD
Organizational Affiliation
University of Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAYMOND POINCARE Hospital
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33887060
Citation
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.
Results Reference
derived
Learn more about this trial
Instrumental and Manual Increase of Couch in Neuromuscular Patients
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