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OpenTrials
Completed

NCT Number: NCT02847299

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

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

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Key information

Conditions

Neuromuscular Disease Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP Hopital R. Poincaré

Garches, Île-de-France Region, 92380, France

About this study

Primary outcome : Peak Expiratory Flow (PEF)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

increase of cough peak flow ("Astral ventilator")

Device

instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method

Primary outcomes

  1. Peak cough flow

    Time frame: 1 year

Secondary outcomes

  1. effective cough time

    Time frame: 1 year

  2. inspired volume

    Time frame: 1 year

  3. maximal expired volume

    Time frame: 1 year

  4. respiratory comfort (Visual Analog Scale)

    Time frame: 1 year

  5. subjective patient's effectiveness of cough (Visual Analog Scale)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • ResMed

Registry information

Acronym: TWOTECH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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