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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
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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
Primary outcome : Peak Expiratory Flow (PEF)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astral ventilator | Experimental | instrumental increase of cough peak flow with air stacking |
|
| Astral ventilator - mode kiné | Experimental | instrumental increase of cough peak flow with hyperinsufflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak cough flow | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| effective cough time | 1 year | |
| inspired volume | 1 year | |
| maximal expired volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic LOFASO, Pr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Hopital R. Poincaré | Garches | Île-de-France Region | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9377912 | Background | 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. | |
| 11083691 | 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. |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| 1 year |
| respiratory comfort (Visual Analog Scale) | 1 year |
| subjective patient's effectiveness of cough (Visual Analog Scale) | 1 year |
| 12023596 | 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. |
| 18539722 | 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. |
| 12172066 | Background | 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. |
| 17057639 | 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. |
| 15302625 | 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. |
| 10893360 | Background | Kang SW, Bach JR. Maximum insufflation capacity. Chest. 2000 Jul;118(1):61-5. doi: 10.1378/chest.118.1.61. |
| 8181348 | 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. |
| 16867201 | Background | Boitano LJ. Management of airway clearance in neuromuscular disease. Respir Care. 2006 Aug;51(8):913-22; discussion 922-4. |
| 9725800 | 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. |
| 15766917 | 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. |
| 19245730 | 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. |
| 11359958 | 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. |
| 12662009 | 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. |
| 15668554 | 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. |
| 16244522 | 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. |
| 19863831 | 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. |
| 8222823 | 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. |
| 25171575 | 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. |
| 19918629 | 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. |
| 18071020 | 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. |
| 16642546 | 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. |
| 15078752 | 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. |
| 15364756 | 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. |