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Neuromuscular DiseaseTWOTECHNCT02847299

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

A study testing increase of cough peak flow ("Astral ventilator") in people with Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuromuscular Disease
What is being tested?
increase of cough peak flow ("Astral ventilator")
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
Sep 2016to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP Hopital R. Poincaré

    Garches, Île-de-France Region, 92380

Other trials in France

About this study

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

Read the detailed description

Primary outcome : Peak Expiratory Flow (PEF)

Being tested
increase of cough peak flow ("Astral ventilator")
Keywords
cough help, mechanical insufflation, mechanical ventilation, neuromuscular diseases, peak cough flow
Medical subject headings
Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT02847299
Study groupRoleWhat they receive
Astral ventilatorExperimentalinstrumental increase of cough peak flow with air stacking
Receives: Device: increase of cough peak flow ("Astral ventilator")
Astral ventilator - mode kinéExperimentalinstrumental increase of cough peak flow with hyperinsufflation
Receives: Device: increase of cough peak flow ("Astral ventilator")

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak cough flow

    Measured: 1 year

Secondary outcomes (5)

  1. effective cough time

    Measured: 1 year

  2. inspired volume

    Measured: 1 year

  3. maximal expired volume

    Measured: 1 year

  4. respiratory comfort (Visual Analog Scale)

    Measured: 1 year

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847299
Sponsor's protocol ID
2015-A00171-48
Acronym
TWOTECH
Status last verified
Apr 2017
First submitted
1 Mar 2016
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997 Oct;112(4):1024-8. doi: 10.1378/chest.112.4.1024.

    PubMed 9377912

  • Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6. doi: 10.1378/chest.118.5.1390.

    PubMed 11083691

  • Gomez-Merino E, Bach JR. Duchenne muscular dystrophy: prolongation of life by noninvasive ventilation and mechanically assisted coughing. Am J Phys Med Rehabil. 2002 Jun;81(6):411-5. doi: 10.1097/00002060-200206000-00003.

    PubMed 12023596

  • Soudon P, Steens M, Toussaint M. A comparison of invasive versus noninvasive full-time mechanical ventilation in Duchenne muscular dystrophy. Chron Respir Dis. 2008;5(2):87-93. doi: 10.1177/1479972308088715.

    PubMed 18539722

  • Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.

    PubMed 12172066

  • Leger P, Paulus J. [Recommendations of HAS: Practical issues in home non-invasive ventilation in patients with neuromuscular disease]. Rev Mal Respir. 2006 Sep;23(4 Suppl):13S141-3. No abstract available. French.

    PubMed 17057639

  • Finder JD, Birnkrant D, Carl J, Farber HJ, Gozal D, Iannaccone ST, Kovesi T, Kravitz RM, Panitch H, Schramm C, Schroth M, Sharma G, Sievers L, Silvestri JM, Sterni L; American Thoracic Society. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am J Respir Crit Care Med. 2004 Aug 15;170(4):456-65. doi: 10.1164/rccm.200307-885ST. No abstract available.

    PubMed 15302625

  • Kang SW, Bach JR. Maximum insufflation capacity. Chest. 2000 Jul;118(1):61-5. doi: 10.1378/chest.118.1.61.

    PubMed 10893360

  • Bach JR. Update and perspective on noninvasive respiratory muscle aids. Part 2: The expiratory aids. Chest. 1994 May;105(5):1538-44. doi: 10.1378/chest.105.5.1538. No abstract available.

    PubMed 8181348

  • Boitano LJ. Management of airway clearance in neuromuscular disease. Respir Care. 2006 Aug;51(8):913-22; discussion 922-4.

    PubMed 16867201

  • Irwin RS, Boulet LP, Cloutier MM, Fuller R, Gold PM, Hoffstein V, Ing AJ, McCool FD, O'Byrne P, Poe RH, Prakash UB, Pratter MR, Rubin BK. Managing cough as a defense mechanism and as a symptom. A consensus panel report of the American College of Chest Physicians. Chest. 1998 Aug;114(2 Suppl Managing):133S-181S. doi: 10.1378/chest.114.2_supplement.133s. No abstract available.

    PubMed 9725800

  • Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphael JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300. doi: 10.1016/j.resp.2005.01.001.

    PubMed 15766917

  • Toussaint M, Boitano LJ, Gathot V, Steens M, Soudon P. Limits of effective cough-augmentation techniques in patients with neuromuscular disease. Respir Care. 2009 Mar;54(3):359-66.

    PubMed 19245730

  • Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.

    PubMed 11359958

  • Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8. doi: 10.1183/09031936.03.00048102.

    PubMed 12662009

Questions about this trial

What is this clinical trial studying?

A study testing increase of cough peak flow ("Astral ventilator") in people with Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak cough flow (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02847299, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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