Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis
NCT ID: NCT07170865
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-09-01
2026-10-15
Brief Summary
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Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.
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Detailed Description
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* Diaphragmatic excursion using M-mode ultrasound with a low-frequency convex (abdominal) probe via a subcostal approach
* Diaphragmatic thickening using B-mode ultrasound with a high-frequency linear (vascular) probe via the lateral axillary line
Measurements will be obtained during spontaneous breathing and after 10 to 20 minutes of non-invasive ventilation (NIV), using ventilator settings deemed optimally adjusted by the supervising physician.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient refusal to participate
* Individual under legal guardianship or judicial protection
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Christel Saint Raymond, Doctor
Role: STUDY_DIRECTOR
CHU Grenoble Alpes
Locations
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CHU Grenoble-Alpes
Grenoble, Isère, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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38RC25.0186
Identifier Type: -
Identifier Source: org_study_id
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