Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

NCT07170865 | Not Yet Recruiting

• 1 other identifier: 38RC25.0186
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and diaphragmatic thickening between spontaneous breathing and non-invasive ventilation ? Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.

Conditions

Amyotrophic Lateral Sclerosis (ALS); Non Invasive Ventilation (NIV)

Keywords

Amyotrophic Lateral Sclerosis (ALS); Non invasive ventilation (NIV); Diaphragmatic ultrasound; diaphragmatic excursion; ultrasound; diaphragmatic thickening

Outcome Measures

Primary Outcomes (1)

• Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)

  Both DE and DT will be measured under spontaneous bretahing and under NIV. The outcomes will be compared, and the percentage variation between the two conditions will be recorded

  Day 1

Secondary Outcomes (4)

• Changes in transcutaneous carbon dioxide (TcCO₂) levels

  Day 1

• NIV Tolerance

  Day 1

• Pathophysiological type of ALS

  Day 1

• Adherence of NIV

  Day 1

Eligibility Criteria

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

Study Population

Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist

You may qualify if:

• Adult patient (≥18 years old)
• Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist
• Indication for non-invasive ventilation (NIV) confirmed by the referring pulmonologist for daytime and/or nocturnal alveolar hypoventilation

You may not qualify if:

• Continuous (24-hour) non-invasive ventilation
• Patient refusal to participate
• Individual under legal guardianship or judicial protection

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, Isère, 38043, France

Location

Related Publications (17)

• Georges M, Perez T, Rabec C, Jacquin L, Finet-Monnier A, Ramos C, Patout M, Attali V, Amador M, Gonzalez-Bermejo J, Salachas F, Morelot-Panzini C. Proposals from a French expert panel for respiratory care in ALS patients. Respir Med Res. 2022 May;81:100901. doi: 10.1016/j.resmer.2022.100901. Epub 2022 Mar 3.

  PMID: 35378353 BACKGROUND

• Kang HW, Kim TO, Lee BR, Yu JY, Chi SY, Ban HJ, Oh IJ, Kim KS, Kwon YS, Kim YI, Kim YC, Lim SC. Influence of diaphragmatic mobility on hypercapnia in patients with chronic obstructive pulmonary disease. J Korean Med Sci. 2011 Sep;26(9):1209-13. doi: 10.3346/jkms.2011.26.9.1209. Epub 2011 Sep 1.

  PMID: 21935278 BACKGROUND

• Cammarota G, Sguazzotti I, Zanoni M, Messina A, Colombo D, Vignazia GL, Vetrugno L, Garofalo E, Bruni A, Navalesi P, Avanzi GC, Della Corte F, Volpicelli G, Vaschetto R. Diaphragmatic Ultrasound Assessment in Subjects With Acute Hypercapnic Respiratory Failure Admitted to the Emergency Department. Respir Care. 2019 Dec;64(12):1469-1477. doi: 10.4187/respcare.06803. Epub 2019 Aug 27.

  PMID: 31455684 BACKGROUND

• Qian Z, Yang M, Li L, Chen Y. Ultrasound assessment of diaphragmatic dysfunction as a predictor of weaning outcome from mechanical ventilation: a systematic review and meta-analysis. BMJ Open. 2018 Oct 4;8(9):e021189. doi: 10.1136/bmjopen-2017-021189.

  PMID: 30287605 BACKGROUND

• Marques MR, Pereira JM, Paiva JA, de Casasola-Sanchez GG, Tung-Chen Y. Ultrasonography to Access Diaphragm Dysfunction and Predict the Success of Mechanical Ventilation Weaning in Critical Care: A Narrative Review. J Ultrasound Med. 2024 Feb;43(2):223-236. doi: 10.1002/jum.16363. Epub 2023 Nov 2.

  PMID: 37915259 BACKGROUND

• Pinto S, Alves P, Pimentel B, Swash M, de Carvalho M. Ultrasound for assessment of diaphragm in ALS. Clin Neurophysiol. 2016 Jan;127(1):892-897. doi: 10.1016/j.clinph.2015.03.024. Epub 2015 Apr 25.

  PMID: 25971723 BACKGROUND

• Fantini R, Mandrioli J, Zona S, Antenora F, Iattoni A, Monelli M, Fini N, Tonelli R, Clini E, Marchioni A. Ultrasound assessment of diaphragmatic function in patients with amyotrophic lateral sclerosis. Respirology. 2016 Jul;21(5):932-8. doi: 10.1111/resp.12759. Epub 2016 Mar 19.

  PMID: 26994409 BACKGROUND

• Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006 Feb;5(2):140-7. doi: 10.1016/S1474-4422(05)70326-4.

  PMID: 16426990 BACKGROUND

• Su WM, Cheng YF, Jiang Z, Duan QQ, Yang TM, Shang HF, Chen YP. Predictors of survival in patients with amyotrophic lateral sclerosis: A large meta-analysis. EBioMedicine. 2021 Dec;74:103732. doi: 10.1016/j.ebiom.2021.103732. Epub 2021 Dec 1.

  PMID: 34864363 BACKGROUND

• Brown RH, Al-Chalabi A. Amyotrophic Lateral Sclerosis. N Engl J Med. 2017 Jul 13;377(2):162-172. doi: 10.1056/NEJMra1603471. No abstract available.

  PMID: 28700839 BACKGROUND

• 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.

  PMID: 16899545 BACKGROUND

• Schenesse D, Mouillot P, Rabec C, Barnestein R, Tankere P, Giboulot M, Bonniaud P, Georges M. [Diaphragmatic ultrasonography for the pulmonologist: Technique and clinical use]. Rev Mal Respir. 2024 Jan;41(1):1-17. doi: 10.1016/j.rmr.2023.10.005. Epub 2023 Nov 18. French.

  PMID: 37980184 BACKGROUND

• Boussuges A, Bregeon F, Blanc P, Gil JM, Poirette L. Characteristics of the paralysed diaphragm studied by M-mode ultrasonography. Clin Physiol Funct Imaging. 2019 Mar;39(2):143-149. doi: 10.1111/cpf.12549. Epub 2018 Oct 16.

  PMID: 30325572 BACKGROUND

• Hiwatani Y, Sakata M, Miwa H. Ultrasonography of the diaphragm in amyotrophic lateral sclerosis: clinical significance in assessment of respiratory functions. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Mar;14(2):127-31. doi: 10.3109/17482968.2012.729595. Epub 2012 Oct 30.

  PMID: 23110443 BACKGROUND

• Fantini R, Tonelli R, Castaniere I, Tabbi L, Pellegrino MR, Cerri S, Livrieri F, Giaroni F, Monelli M, Ruggieri V, Fini N, Mandrioli J, Clini E, Marchioni A. Serial ultrasound assessment of diaphragmatic function and clinical outcome in patients with amyotrophic lateral sclerosis. BMC Pulm Med. 2019 Aug 27;19(1):160. doi: 10.1186/s12890-019-0924-5.

  PMID: 31455341 BACKGROUND

• Spiliopoulos KC, Lykouras D, Veltsista D, Skaramagkas V, Karkoulias K, Tzouvelekis A, Chroni E. The utility of diaphragm ultrasound thickening indices for assessing respiratory decompensation in amyotrophic lateral sclerosis. Muscle Nerve. 2023 Nov;68(6):850-856. doi: 10.1002/mus.27980. Epub 2023 Oct 10.

  PMID: 37814924 BACKGROUND

• Czaplinski A, Yen AA, Appel SH. Forced vital capacity (FVC) as an indicator of survival and disease progression in an ALS clinic population. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):390-2. doi: 10.1136/jnnp.2005.072660.

  PMID: 16484652 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Christel Saint Raymond, Doctor

  CHU Grenoble Alpes

  STUDY DIRECTOR

Central Study Contacts

Christel Saint Raymond, Doctor

CONTACT

+33 4 76 76 54 53; CSaint-raymond@chu-grenoble.fr

Hugo Vanderstraete, Resident

CONTACT

+33 6 78 34 08 51; hvanderstraete@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-06

Locations

FR (1)