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Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation (TWOTECH)

Primary Purpose

Neuromuscular Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
increase of cough peak flow ("Astral ventilator")
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuromuscular Disease focused on measuring cough help, mechanical insufflation, mechanical ventilation, neuromuscular diseases, peak cough flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age>18 years, neuromuscular disease,
  • restrictive syndrome and/or cough peak flow < 270.l/mn and/or maximal expiratory pressure < 40 cm HO2,
  • patient under non invasive ventilation
  • steady state for at least one month
  • written consent form given

Exclusion Criteria:

  • bronchial congestion
  • hemodynamic instability
  • previous pneumothorax or emphysema bubbles
  • Major bulbar dysfunction
  • plan of legal protection
  • pregnant or breastfeeding women
  • no affiliation to a social security scheme

Sites / Locations

  • AP-HP Hopital R. Poincaré

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Astral ventilator

Astral ventilator - mode kiné

Arm Description

instrumental increase of cough peak flow with air stacking

instrumental increase of cough peak flow with hyperinsufflation

Outcomes

Primary Outcome Measures

Peak cough flow

Secondary Outcome Measures

effective cough time
inspired volume
maximal expired volume
respiratory comfort (Visual Analog Scale)
subjective patient's effectiveness of cough (Visual Analog Scale)

Full Information

First Posted
March 1, 2016
Last Updated
April 19, 2017
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02847299
Brief Title
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Acronym
TWOTECH
Official Title
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation . The study is a Cross-over, monocentric and open label study
Detailed Description
Primary outcome : Peak Expiratory Flow (PEF)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disease
Keywords
cough help, mechanical insufflation, mechanical ventilation, neuromuscular diseases, peak cough flow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astral ventilator
Arm Type
Experimental
Arm Description
instrumental increase of cough peak flow with air stacking
Arm Title
Astral ventilator - mode kiné
Arm Type
Experimental
Arm Description
instrumental increase of cough peak flow with hyperinsufflation
Intervention Type
Device
Intervention Name(s)
increase of cough peak flow ("Astral ventilator")
Intervention Description
instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method
Primary Outcome Measure Information:
Title
Peak cough flow
Time Frame
1 year
Secondary Outcome Measure Information:
Title
effective cough time
Time Frame
1 year
Title
inspired volume
Time Frame
1 year
Title
maximal expired volume
Time Frame
1 year
Title
respiratory comfort (Visual Analog Scale)
Time Frame
1 year
Title
subjective patient's effectiveness of cough (Visual Analog Scale)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age>18 years, neuromuscular disease, restrictive syndrome and/or cough peak flow < 270.l/mn and/or maximal expiratory pressure < 40 cm HO2, patient under non invasive ventilation steady state for at least one month written consent form given Exclusion Criteria: bronchial congestion hemodynamic instability previous pneumothorax or emphysema bubbles Major bulbar dysfunction plan of legal protection pregnant or breastfeeding women no affiliation to a social security scheme
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic LOFASO, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP Hopital R. Poincaré
City
Garches
State/Province
Ile de France
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
9377912
Citation
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Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation

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