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Trial record 2 of 2 for:    15078752 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02847299
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

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


Condition or disease Intervention/treatment Phase
Neuromuscular Disease Device: increase of cough peak flow ("Astral ventilator") Not Applicable

Detailed Description:
Primary outcome : Peak Expiratory Flow (PEF)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Peak cough flow [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847299


Locations
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France
AP-HP Hopital R. Poincaré
Garches, Ile de France, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
ResMed
Investigators
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Principal Investigator: Frederic LOFASO, Pr Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02847299     History of Changes
Other Study ID Numbers: 2015-A00171-48
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
cough help
mechanical insufflation
mechanical ventilation
neuromuscular diseases
peak cough flow

Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases