Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis (ALS), Non Invasive Ventilation (NIV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of the Dynamic Impact of Non-Invasive Ventilation on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis
Overview
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.
Detailed description
Each diaphragmatic ultrasound assessment will be performed on both the right and left hemidiaphragms, with the patient in a semi-recumbent position at 30°, during a maximal inspiratory effort. The following parameters will be measured:
* 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.
Primary outcome measures
- Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT) [Time frame: Day 1]
Secondary outcome measures (4)
- Changes in transcutaneous carbon dioxide (TcCO₂) levels [Time frame: Day 1]
- NIV Tolerance [Time frame: Day 1]
- Pathophysiological type of ALS [Time frame: Day 1]
- Adherence of NIV [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Continuous (24-hour) non-invasive ventilation
- Patient refusal to participate
- Individual under legal guardianship or judicial protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Grenoble-Alpes — Grenoble
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07170865 · 38RC25.0186