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

NCT02847299 | Completed

• 1 other identifier: 2015-A00171-48
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Neuromuscular Disease

Keywords

cough help; mechanical insufflation; mechanical ventilation; neuromuscular diseases; peak cough flow

Outcome Measures

Primary Outcomes (1)

• Peak cough flow

  1 year

Secondary Outcomes (5)

• effective cough time

  1 year

• inspired volume

  1 year

• maximal expired volume

  1 year

• respiratory comfort (Visual Analog Scale)

  1 year

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

  1 year

Study Arms (2)

Astral ventilator

EXPERIMENTAL

instrumental increase of cough peak flow with air stacking

Device: increase of cough peak flow ("Astral ventilator")

Astral ventilator - mode kiné

EXPERIMENTAL

instrumental increase of cough peak flow with hyperinsufflation

Device: increase of cough peak flow ("Astral ventilator")

Interventions

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

Astral ventilator; Astral ventilator - mode kiné

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• ResMed: collaborator

Study Sites (1)

AP-HP Hopital R. Poincaré

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

Location

Related Publications (25)

• 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.

  PMID: 9377912 BACKGROUND

• 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.

  PMID: 11083691 BACKGROUND

• 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.

  PMID: 12023596 BACKGROUND

• 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.

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• 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.

  PMID: 12172066 BACKGROUND

• 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.

  PMID: 17057639 BACKGROUND

• 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.

  PMID: 15302625 BACKGROUND

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

  PMID: 10893360 BACKGROUND

• 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.

  PMID: 8181348 BACKGROUND

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

  PMID: 16867201 BACKGROUND

• 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.

  PMID: 9725800 BACKGROUND

• 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.

  PMID: 15766917 BACKGROUND

• 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.

  PMID: 19245730 BACKGROUND

• 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.

  PMID: 11359958 BACKGROUND

• 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.

  PMID: 12662009 BACKGROUND

• Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91. doi: 10.1097/01.phm.0000151941.97266.96.

  PMID: 15668554 BACKGROUND

• Servera E, Sancho J, Zafra MJ, Catala A, Vergara P, Marin J. Alternatives to endotracheal intubation for patients with neuromuscular diseases. Am J Phys Med Rehabil. 2005 Nov;84(11):851-7. doi: 10.1097/01.phm.0000184097.17189.93.

  PMID: 16244522 BACKGROUND

• Chatwin M, Simonds AK. The addition of mechanical insufflation/exsufflation shortens airway-clearance sessions in neuromuscular patients with chest infection. Respir Care. 2009 Nov;54(11):1473-9.

  PMID: 19863831 BACKGROUND

• Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62. doi: 10.1378/chest.104.5.1553.

  PMID: 8222823 BACKGROUND

• Lacombe M, Del Amo Castrillo L, Bore A, Chapeau D, Horvat E, Vaugier I, Lejaille M, Orlikowski D, Prigent H, Lofaso F. Comparison of three cough-augmentation techniques in neuromuscular patients: mechanical insufflation combined with manually assisted cough, insufflation-exsufflation alone and insufflation-exsufflation combined with manually assisted cough. Respiration. 2014;88(3):215-22. doi: 10.1159/000364911. Epub 2014 Aug 21.

  PMID: 25171575 BACKGROUND

• Brito MF, Moreira GA, Pradella-Hallinan M, Tufik S. Air stacking and chest compression increase peak cough flow in patients with Duchenne muscular dystrophy. J Bras Pneumol. 2009 Oct;35(10):973-9. doi: 10.1590/s1806-37132009001000005. English, Portuguese.

  PMID: 19918629 BACKGROUND

• Fauroux B, Guillemot N, Aubertin G, Nathan N, Labit A, Clement A, Lofaso F. Physiologic benefits of mechanical insufflation-exsufflation in children with neuromuscular diseases. Chest. 2008 Jan;133(1):161-8. doi: 10.1378/chest.07-1615. Epub 2007 Dec 10.

  PMID: 18071020 BACKGROUND

• Kang SW, Kang YS, Sohn HS, Park JH, Moon JH. Respiratory muscle strength and cough capacity in patients with Duchenne muscular dystrophy. Yonsei Med J. 2006 Apr 30;47(2):184-90. doi: 10.3349/ymj.2006.47.2.184.

  PMID: 16642546 BACKGROUND

• Sancho J, Servera E, Diaz J, Marin J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. doi: 10.1378/chest.125.4.1400.

  PMID: 15078752 BACKGROUND

• Winck JC, Goncalves MR, Lourenco C, Viana P, Almeida J, Bach JR. Effects of mechanical insufflation-exsufflation on respiratory parameters for patients with chronic airway secretion encumbrance. Chest. 2004 Sep;126(3):774-80. doi: 10.1378/chest.126.3.774.

  PMID: 15364756 BACKGROUND

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Frederic LOFASO, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: July 28, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

FR (1)