Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU

NCT04658498 | Recruiting

• 1 other identifier: S64871
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU mortality. Despite a strong theoretical rationale and some evidence supporting the use of inspiratory muscle training (IMT) to address respiratory muscle weakness and atrophy, the optimal approach to IMT remains largely uncertain. In fact, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been conducted so far. The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that patients will be exposed to during their period of weaning from mechanical ventilation.

Conditions

Weaning Failure

Keywords

ICU acquired muscle weakness; IMT; Weaning outcomes; Maximal inspiratory pressure; Diaphragm EMG; Surface EMG; Diaphragm ultrasounds; Microbiopsies; Difficult to wean patients; Respiratory muscles

Outcome Measures

Primary Outcomes (1)

• Maximal Inspiratory Pressure (PImax)

  Using a unidirectional valve which will be connected to the patient's tracheostomy tube or endotracheal tube for an uninterrupted period of 25 seconds.

  Maximal duration of IMT treatment: 28 days

Secondary Outcomes (14)

• Diaphragm mobility, thickness and thickening fraction by ultrasounds

  Maximal duration of IMT treatment: 28 days

• Change in contractile material and structural alteration of sternocleidomastoid muscle

  Maximal duration of IMT treatment: 28 days

• Change in fiber proportion of sternocleidomastoid muscle fibers

  Maximal duration of IMT treatment: 28 days

• Change in size of sternocleidomastoid muscle fibers

  Maximal duration of IMT treatment: 28 days

• Change in amount of satellite cells of sternocleidomastoid muscle

  Maximal duration of IMT treatment: 28 days

Study Arms (3)

Usual Care (UC)

EXPERIMENTAL

Intermittent spontaneous breathing periods

Other: Procedure: Usual Care (UC)

UC + High-intensity inspiratory muscle training (HI-IMT)

EXPERIMENTAL

Other: Procedure: UC + HI-IMT

UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT)

EXPERIMENTAL

Other: Procedure: UC + LI-IMT (sham IMT)

Interventions

Procedure: Usual Care (UC) OTHER

Intermittent spontaneous breathing periods

Usual Care (UC)

Procedure: UC + HI-IMT OTHER

UC + Supervised daily sessions of training including 4 sets of 6-10 full vital capacity breaths against an external load using a tapered flow resistive device (POWERbreathe KH2, HaB International, UK). The maximum tolerable resistance allowing patients to inhale at least 70% of their inspiratory vital capacity will be chosen and progressively increased throughout the training period.

UC + High-intensity inspiratory muscle training (HI-IMT)

Procedure: UC + LI-IMT (sham IMT) OTHER

UC + superrvised daily sessions of training including 4 sets of 6-10 breaths at the lowest external imposable load with the tapered flow resistive device (POWERbreathe KH2, HaB International, UK) (i.e. 3 cmH2O).

UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT)

Eligibility Criteria

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

You may qualify if:

• Difficult and prolonged weaning patients
• Adequate oxygenation
• Febrile temperature \< 38ºC
• Hemodynamic stability
• Stable blood pressure
• No or minimal vasopressors
• No myocardial ischemia
• Adequate hemoglobin and mentation
• Resolution of disease acute phase
• Able to follow simple verbal commands related to IMT
• Mechanically ventilated via a tracheostomy or endotracheal tube

You may not qualify if:

• Pre-existing neuromuscular disease
• Agitation
• Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)
• Hemoptysis
• Diaphoresis
• Spinal cord injury above T8
• Use of any type of home MV support prior to hospitalization
• Skeletal pathology that impairs chest wall movements
• Poor general prognosis or fatal outcome

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (9)

• Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.

  PMID: 28917004 BACKGROUND

• Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.

  PMID: 29584447 BACKGROUND

• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

  PMID: 23786764 BACKGROUND

• Dres M, Goligher EC, Dube BP, Morawiec E, Dangers L, Reuter D, Mayaux J, Similowski T, Demoule A. Diaphragm function and weaning from mechanical ventilation: an ultrasound and phrenic nerve stimulation clinical study. Ann Intensive Care. 2018 Apr 23;8(1):53. doi: 10.1186/s13613-018-0401-y.

  PMID: 29687276 BACKGROUND

• Elkins M, Dentice R. Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review. J Physiother. 2015 Jul;61(3):125-34. doi: 10.1016/j.jphys.2015.05.016. Epub 2015 Jun 16.

  PMID: 26092389 BACKGROUND

• Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.

  PMID: 25858974 BACKGROUND

• Hoffman M, Van Hollebeke M, Clerckx B, Muller J, Louvaris Z, Gosselink R, Hermans G, Langer D. Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study). BMJ Open. 2018 Jun 30;8(6):e021091. doi: 10.1136/bmjopen-2017-021091.

  PMID: 29961023 BACKGROUND

• Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

  PMID: 30956204 BACKGROUND

• Poddighe D, Van Hollebeke M, Clerckx B, Janssens L, Molenberghs G, Van Dyck L, Muller J, Gunst J, Meersseman P, Peetermans M, Hermans G, Gosselink R, Langer D. Inspiratory effort and respiratory muscle activation during different breathing conditions in patients with weaning difficulties: An exploratory study. Aust Crit Care. 2025 May;38(3):101152. doi: 10.1016/j.aucc.2024.101152. Epub 2025 Jan 21.

  PMID: 39842329 DERIVED

Central Study Contacts

Daniel Langer, PT, PhD

CONTACT

+3216330192; daniel.langer@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Model Details: Double-blind, three arms parallel group randomized controlled trial with 1:1:1 allocation ratio

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 8, 2020
• Study Start: February 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BE (1)