Volume Mode Non-invasive Ventilation in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT05328492

Recruitment Status : Recruiting

First Posted : April 14, 2022

Last Update Posted : April 29, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

University Hospitals Coventry and Warwickshire NHS Trust

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 15, 2023
Estimated Study Completion Date :	March 15, 2024

Publications:

Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. [Causes of death in amyotrophic lateral sclerosis : Results from the Rhineland-Palatinate ALS registry]. Nervenarzt. 2017 Aug;88(8):911-918. doi: 10.1007/s00115-017-0293-3. German.

Goetz CG. Amyotrophic lateral sclerosis: early contributions of Jean-Martin Charcot. Muscle Nerve. 2000 Mar;23(3):336-43. doi: 10.1002/(sici)1097-4598(200003)23:33.0.co;2-l.

Raheja D, Stephens HE, Lehman E, Walsh S, Yang C, Simmons Z. Patient-reported problematic symptoms in an ALS treatment trial. Amyotroph Lateral Scler Frontotemporal Degener. 2016;17(3-4):198-205. doi: 10.3109/21678421.2015.1131831. Epub 2016 Jan 29.

Arnulf I, Similowski T, Salachas F, Garma L, Mehiri S, Attali V, Behin-Bellhesen V, Meininger V, Derenne JP. Sleep disorders and diaphragmatic function in patients with amyotrophic lateral sclerosis. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):849-56. doi: 10.1164/ajrccm.161.3.9805008.

NICE. Recommendations | Motor neurone disease: assessment and management | Guidance | NICE [Internet]. NICE; 2016 [cited 2021 May 10]. Available from: https://www.nice.org.uk/guidance/NG42/chapter/Recommendations#prognostic-factors

Ristell HV, Parkes E, Shakespeare J, Bishopp A, Ali A, Parr D. Non-invasive Ventilation Compliance and Survival Trends in Motor Neurone Disease. European Respiratory Journal [Internet]. 2019 Sep 28 [cited 2021 May 5];54(suppl 63). Available from: https://erj.ersjournals.com/content/54/suppl_63/PA3705

Nicholson TT, Smith SB, Siddique T, Sufit R, Ajroud-Driss S, Coleman JM 3rd, Wolfe LF. Respiratory Pattern and Tidal Volumes Differ for Pressure Support and Volume-assured Pressure Support in Amyotrophic Lateral Sclerosis. Ann Am Thorac Soc. 2017 Jul;14(7):1139-1146. doi: 10.1513/AnnalsATS.201605-346OC.

Gruis KL, Brown DL, Lisabeth LD, Zebarah VA, Chervin RD, Feldman EL. Longitudinal assessment of noninvasive positive pressure ventilation adjustments in ALS patients. J Neurol Sci. 2006 Aug 15;247(1):59-63. doi: 10.1016/j.jns.2006.03.007. Epub 2006 Apr 24.

Lo Coco D, Marchese S, Pesco MC, La Bella V, Piccoli F, Lo Coco A. Noninvasive positive-pressure ventilation in ALS: predictors of tolerance and survival. Neurology. 2006 Sep 12;67(5):761-5. doi: 10.1212/01.wnl.0000227785.73714.64. Epub 2006 Aug 9.

Kim SM, Park KS, Nam H, Ahn SW, Kim S, Sung JJ, Lee KW. Capnography for assessing nocturnal hypoventilation and predicting compliance with subsequent noninvasive ventilation in patients with ALS. PLoS One. 2011 Mar 30;6(3):e17893. doi: 10.1371/journal.pone.0017893.

Mansell SK, Cutts S, Hackney I, Wood MJ, Hawksworth K, Creer DD, Kilbride C, Mandal S. Using domiciliary non-invasive ventilator data downloads to inform clinical decision-making to optimise ventilation delivery and patient compliance. BMJ Open Respir Res. 2018 Mar 3;5(1):e000238. doi: 10.1136/bmjresp-2017-000238. eCollection 2018.

Rudnicki SA, Andrews JA, Bian A, Cockroft BM, Cudkowicz ME, Hardiman O, Malik FI, Meng L, Wolff AA, Shefner JM; VITALITY-ALS STUDY GROUP. Noninvasive ventilation use by patients enrolled in VITALITY-ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2021 Nov;22(7-8):486-494. doi: 10.1080/21678421.2021.1904993. Epub 2021 Apr 1.

Vitacca M, Banfi P, Montini A, Paneroni M. Does timing of initiation influence acceptance and adherence to NIV in patients with ALS? Pulmonology. 2020 Jan-Feb;26(1):45-48. doi: 10.1016/j.pulmoe.2019.05.007. Epub 2019 Jun 5.

Kleopa KA, Sherman M, Neal B, Romano GJ, Heiman-Patterson T. Bipap improves survival and rate of pulmonary function decline in patients with ALS. J Neurol Sci. 1999 Mar 15;164(1):82-8. doi: 10.1016/s0022-510x(99)00045-3.

Czudaj KP, Suchi S, Schonhofer B. [Physiological parameters of breathing and the impact of non-invasive ventilation (NIV) on patients with amyotrophic lateral sclerosis (ALS)]. Pneumologie. 2009 Dec;63(12):687-92. doi: 10.1055/s-0029-1215130. Epub 2009 Nov 3. German.

Bach JR. Amyotrophic lateral sclerosis. Communication status and survival with ventilatory support. Am J Phys Med Rehabil. 1993 Dec;72(6):343-9. Erratum In: Am J Phys Med Rehabil 1994 Jun;73(3):218.

Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luis ML. Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26. doi: 10.1016/0022-510x(95)00052-4.

Rabec C, Rodenstein D, Leger P, Rouault S, Perrin C, Gonzalez-Bermejo J; SomnoNIV group. Ventilator modes and settings during non-invasive ventilation: effects on respiratory events and implications for their identification. Thorax. 2011 Feb;66(2):170-8. doi: 10.1136/thx.2010.142661. Epub 2010 Oct 14.

Sancho J, Servera E, Morelot-Panzini C, Salachas F, Similowski T, Gonzalez-Bermejo J. Non-invasive ventilation effectiveness and the effect of ventilatory mode on survival in ALS patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Mar;15(1-2):55-61. doi: 10.3109/21678421.2013.855790. Epub 2013 Nov 25.

Morelot-Panzini C, Bruneteau G, Gonzalez-Bermejo J. NIV in amyotrophic lateral sclerosis: The 'when' and 'how' of the matter. Respirology. 2019 Jun;24(6):521-530. doi: 10.1111/resp.13525. Epub 2019 Mar 25.

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