Instrumental and Manual Increase of Couch in Neuromuscula... | NCT01518439

Studies
Instrumental and Manual Increase of Couch in Neuromuscular Patients

NCT01518439

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Jul 19, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Neuromuscular Disease
Chronic Respiratory Failure
Coughing

Interventions

Alpha 200®
Alpha 200® + physiotherapist
Cough Assist®
Cough Assist® + physiotherapist
physiotherapist

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 11, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2013

Last Update Posted Date

Jul 19, 2013Estimated

Name	Class
Adep Assistance	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neuromuscular patients	Experimental	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion	Device: Alpha 200® Device: Alpha 200® + physiotherapist Device: Cough Assist® Device: Cough Assist® + physiotherapist Other: physiotherapist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alpha 200®	Device	inspiratory capacity is increased with the use of constant pressure device: Alpha 200®	neuromuscular patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cough flow obtained from the combination of mechanical and manual cough assistance techniques		2 Hours

Secondary Outcomes

Measure	Description	Time Frame
duration of efficient cough flow (above 180 l/min)under each cough assistance technique		2 Hours
respiratory comfort	evaluation with a visual analogical scale	2 Hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederic Lofaso, Md-PhD	University of Versailles	Study Director
Helene Prigent, MD-PhD	University of Versailles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RAYMOND POINCARE Hospital		Garches	Garches	92380	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33887060	Derived	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.

ID	Term
D009468	Neuromuscular Diseases
D003371	Cough

ID	Term
D009422	Nervous System Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory

ID	Term
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services