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  • Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study)

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Rehabilitation medicine
Protocol
Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study)
  1. Mariana Hoffman1,2,3,
  2. Marine Van Hollebeke2,3,
  3. Beatrix Clerckx2,3,
  4. Johannes Muller3,
  5. Zafeiris Louvaris2,3,
  6. Rik Gosselink2,3,
  7. Greet Hermans4,5,
  8. Daniel Langer2,3
  1. 1 Federal University of Minas Gerais, Rehabilitation Sciences Program, Belo Horizonte, Brazil
  2. 2 KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium
  3. 3 Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium
  4. 4 Medical Intensive Care Unit, Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium
  5. 5 Laboratory of Intensive Care Medicine, Division of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium
  1. Correspondence to Dr Mariana Hoffman; mariana_hoffmanb{at}yahoo.com.br

Abstract

Introduction Respiratory muscle dysfunction has been associated with failure to wean from mechanical ventilation. It has therefore been hypothesised that these patients might benefit from inspiratory muscle training (IMT). Evidence, however, is thus far limited to data from small, single-centre studies with heterogeneity in inclusion criteria, training modalities and outcomes. The aim of this study is to evaluate the effects of a novel IMT method on weaning outcomes in selected patients with weaning difficulties.

Methods This study is designed as a double-blind, parallel-group, randomised controlled superiority trial with 1:1 allocation ratio. Patients with weaning difficulties will be randomly allocated into either an IMT group (intervention) or a sham-IMT group (control). Ninetypatients (45 in each group) will be needed to detect a 28% difference in the proportion of weaning success between groups (estimated difference in primary outcome based on previous studies) with a risk for type I error (α) of 5% and statistical power (1-β) of 80%. Patients will perform four sets of 6–10 breaths daily against an external load using a tapered flow resistive loading device (POWERbreathe KH2, HaB International, UK). Training intensity in the intervention group will be adjusted to the highest tolerable load. The control group will train against a low resistance that will not be modified during the training period. Training will becontinued until patients are successfully weaned or for a maximum duration of 28 days. Pulmonary and respiratory muscle function, weaning duration, duration of mechanical ventilation, ventilator-free days and length of stay in the intensive care unit will be evaluated as secondary outcomes. Χ2 tests and analysis of covariance with adjustments for baseline values of respective outcomesas covariates will be used to compare results after the intervention period between groups.

Ethics and dissemination Ethics approval was obtained from the local ethical committee (Ethische Commissie Onderzoek UZ/KU Leuven protocol ID: S60516). Results from this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peerreviewed journals.

Trial status Enrolment into the study have started in August 2017. Data collection and data analysis are expected to be completed in September 2021.

Trial registration number NCT03240263.

  • respiratory muscle training
  • intensive care units
  • ventilator weaning

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-021091

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    Footnotes

    • MH and MVH contributed equally.

    • Contributors MH, BC, DL and RG are responsible for the overall development of an ethically sound protocol. MH, BC, DL, RG, MVH, ZL, GH and JM are involved in the conception and production of the study and the development of the initial protocol. All authors contributed to the drafting, critical revision and final approval of the document.

    • Funding MH was sponsored by Fundação de Amparo a Pesquisa de Minas Gerais-FAPEMIG/Brazil grant numbers [309494/2013-3 and 442973/2014-4]. ZL is a postdoctoral fellow of the FWO-Flanders (Fellowship number 12U5618N).

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval Ethische Commissie Onderzoek UZ/KU Leuven - protocol ID: S60516.

    • Provenance and peer review Not commissioned; externally peer reviewed.