Inspiratory Muscle Training in Difficult to Wean Patients

NCT03240263 | Completed

• 1 other identifier: S60516
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged mechanical ventilation secondary to weaning failure demands a significant amount of intensive care unit (ICU) resources, thus increasing the economic burden of public healthcare costs. One of the proposed mechanisms accounting for weaning failure is the concept that excessive work of breathing for weak respiratory muscles during the liberation from mechanical ventilation compromises cerebral blood flow, thereby predisposing the brain to dysfunction. Restriction in brain perfusion could have an adverse impact on the function of the respiratory muscles by impairing the output of the respiratory centre thus promoting respiratory muscle fatigue, leading to weaning failure. Inspiratory muscle training (IMT) has been shown to improve the functional capacity of the inspiratory muscles in patients with respiratory muscle weakness whilst has been recently proposed as a possible additional component of weaning strategies. Therefore, this project aims to identify both a mechanism that might be linked to prolong ICU length of stay and that at the same time might be amenable to treatment.

Conditions

Weaning Failure

Keywords

Difficult to wean patients; ICU aquired muscle weakness; Cerebral perfusion; Respiratroy muscles; IMT; Cerebral oxygenation; Weaning outcomes

Outcome Measures

Primary Outcomes (1)

• Weaning Success

  Number of patients who were successfully weaned within 28 days after inclusion. Day of inclusion: 1st day of start of inspiratory muscle training) Weaning success defined for intubated patients as extubation without death or reintubation within 7 days or ICU discharge without invasive mechanical ventilation within 7days. Tracheotomized patients achieved successful weaning by sustaining spontaneous ventilation without ventilatory support for 7 days or being discharged with spontaneous breathing within 7 days.

  Maximal duration of IMT treatment: 28 days

Secondary Outcomes (14)

• Weaning Success at ICU discharge

  Through study completion, an average of 70 days

• Duration of mechanical ventilation

  Maximal duration of IMT treatment: 28 days

• Weaning duration

  Maximal duration of IMT treatment: 28 days

• Weaning duration after inclusion

  Maximal duration of IMT treatment: 28 days

• 28-day ventilator-free days

  Maximal duration of IMT treatment: 28 days

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

High intensity inspiratory muscle training

Procedure: Inspiratory Muscle Training

Sham endurance training

SHAM COMPARATOR

Sham inspiratory muscle training at low intensity

Procedure: Endurance training

Interventions

Inspiratory Muscle Training PROCEDURE

Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device\*. Resistance adjusted to the highest tolerable load. \*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK

Inspiratory muscle training

Endurance training PROCEDURE

Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device\*. Low training resistance adjusted to \<10% maximal inspiratory pressure. \*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK

Sham endurance training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Difficult and prolonged weaning patients
• Simple weaning patients
• Adequate oxygenation
• Febrile temperature \< 38ºC
• Hemodynamic stability
• Stable blood pressure
• No or minimal pressors
• 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

Location

Related Publications (15)

• Vassilakopoulos T, Zakynthinos S, Roussos Ch. Respiratory muscles and weaning failure. Eur Respir J. 1996 Nov;9(11):2383-400. doi: 10.1183/09031936.96.09112383.

  PMID: 8947090 BACKGROUND

• Gosselink R, Langer D. Recovery from ICU-acquired weakness; do not forget the respiratory muscles! Thorax. 2016 Sep;71(9):779-80. doi: 10.1136/thoraxjnl-2016-208835. Epub 2016 Jul 21. No abstract available.

  PMID: 27444580 BACKGROUND

• Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.

  PMID: 26242743 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

• Louvaris Z, Vogiatzis I. Respiratory muscle blood flow measured by Near-Infrared Spectroscopy (NIRS) by indocyanine green dye. In: Aliverti A PA, ed. Mechanics of breathing. Italy: Springler-Verlag, 169-178, 2014.

  BACKGROUND

• Vogiatzis I, Louvaris Z, Habazettl H, Andrianopoulos V, Wagner H, Roussos C, Wagner PD, Zakynthinos S. Cerebral cortex oxygen delivery and exercise limitation in patients with COPD. Eur Respir J. 2013 Feb;41(2):295-301. doi: 10.1183/09031936.00016312. Epub 2012 May 3.

  PMID: 22556019 BACKGROUND

• Boushel R, Langberg H, Olesen J, Gonzales-Alonzo J, Bulow J, Kjaer M. Monitoring tissue oxygen availability with near infrared spectroscopy (NIRS) in health and disease. Scand J Med Sci Sports. 2001 Aug;11(4):213-22. doi: 10.1034/j.1600-0838.2001.110404.x.

  PMID: 11476426 BACKGROUND

• CHERRICK GR, STEIN SW, LEEVY CM, DAVIDSON CS. Indocyanine green: observations on its physical properties, plasma decay, and hepatic extraction. J Clin Invest. 1960 Apr;39(4):592-600. doi: 10.1172/JCI104072. No abstract available.

  PMID: 13809697 BACKGROUND

• Riley RL. The work of breathing and its relation to respiratory acidosis. Annals of Internal Medicine 41:172-176, 1954

  BACKGROUND

• Hermans G, Agten A, Testelmans D, Decramer M, Gayan-Ramirez G. Increased duration of mechanical ventilation is associated with decreased diaphragmatic force: a prospective observational study. Crit Care. 2010;14(4):R127. doi: 10.1186/cc9094. Epub 2010 Jul 1.

  PMID: 20594319 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

• Van Hollebeke M, Poddighe D, Hoffman M, Clerckx B, Muller J, Louvaris Z, Hermans G, Gosselink R, Langer D. Similar Weaning Success Rate with High-Intensity and Sham Inspiratory Muscle Training: A Randomized Controlled Trial (IMweanT). Am J Respir Crit Care Med. 2025 Mar;211(3):381-390. doi: 10.1164/rccm.202405-1042OC.

  PMID: 39565276 DERIVED

• Van Hollebeke M, Pleysier S, Poddighe D, Muelas Gomez L, Choudhary YQ, Clerckx B, Muller J, Hermans G, Gosselink R, Langer D. Comparing two types of loading during inspiratory muscle training in patients with weaning difficulties: An exploratory study. Aust Crit Care. 2023 Jul;36(4):622-627. doi: 10.1016/j.aucc.2022.07.001. Epub 2022 Aug 27.

  PMID: 36041981 DERIVED

• Louvaris Z, Van Hollebeke M, Dhaenens A, Vanhemelen M, Meersseman P, Wauters J, Gosselink R, Wilmer A, Langer D, Hermans G. Cerebral cortex and respiratory muscles perfusion during spontaneous breathing attempts in ventilated patients and its relation to weaning outcomes: a protocol for a prospective observational study. BMJ Open. 2019 Oct 31;9(10):e031072. doi: 10.1136/bmjopen-2019-031072.

  PMID: 31676653 DERIVED

• 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 DERIVED

Related Links

• Institutional Review Board

MeSH Terms

Interventions

Endurance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rik Gosselink, PT, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

BE (1)