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

Neuromuscular Disease Clinical Trial

— TWOTECH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847299
• Other study ID #: 2015-A00171-48
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: April 19, 2017
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

Primary outcome : Peak Expiratory Flow (PEF)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

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

Locations

Country	Name	City	State
France	AP-HP Hopital R. Poincaré	Garches	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	ResMed

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62. — View Citation

Bach JR. Update and perspective on noninvasive respiratory muscle aids. Part 2: The expiratory aids. Chest. 1994 May;105(5):1538-44. Review. — View Citation

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

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. English, Portuguese. — View Citation

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. — View Citation

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. — View Citation

Fauroux B, Guillemot N, Aubertin G, Nathan N, Labit A, Clément A, Lofaso F. Physiologic benefits of mechanical insufflation-exsufflation in children with neuromuscular diseases. Chest. 2008 Jan;133(1):161-8. Epub 2007 Dec 10. — View Citation

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. Review. — View Citation

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. — View Citation

Gómez-Merino E, Sancho J, Marín 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. — View Citation

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. Review. — View Citation

Kang SW, Bach JR. Maximum insufflation capacity. Chest. 2000 Jul;118(1):61-5. — View Citation

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. — View Citation

Lacombe M, Del Amo Castrillo L, Boré 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. — View Citation

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. French. — View Citation

Sancho J, Servera E, Díaz J, Marín J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. — View Citation

Servera E, Sancho J, Zafra MJ, Catalá A, Vergara P, Marín J. Alternatives to endotracheal intubation for patients with neuromuscular diseases. Am J Phys Med Rehabil. 2005 Nov;84(11):851-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphaël JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300. — View Citation

Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6. — View Citation

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. — View Citation

Winck JC, Gonçalves MR, Lourenço 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak cough flow		1 year
Secondary	effective cough time		1 year
Secondary	inspired volume		1 year
Secondary	maximal expired volume		1 year
Secondary	respiratory comfort (Visual Analog Scale)		1 year
Secondary	subjective patient's effectiveness of cough (Visual Analog Scale)		1 year