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

April 19, 2017 updated by: Centre d'Investigation Clinique et Technologique 805

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary outcome : Peak Expiratory Flow (PEF)

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Garches, Ile de France, France, 92380
        • AP-HP Hopital R. Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astral ventilator
instrumental increase of cough peak flow with air stacking
Device: increase of cough peak flow ("Astral ventilator")
instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method
Experimental: Astral ventilator - mode kiné
instrumental increase of cough peak flow with hyperinsufflation
Device: increase of cough peak flow ("Astral ventilator")
instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak cough flow
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
effective cough time
Time Frame: 1 year
1 year
inspired volume
Time Frame: 1 year
1 year
maximal expired volume
Time Frame: 1 year
1 year
respiratory comfort (Visual Analog Scale)
Time Frame: 1 year
1 year
subjective patient's effectiveness of cough (Visual Analog Scale)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

ResMed

Investigators

  • Principal Investigator: Frederic LOFASO, Pr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00171-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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