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Critical Care
Published in: Critical Care 1/2020

Open Access 01-12-2020 | Research

Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis

Authors: Annemijn H. Jonkman, Tim Frenzel, Euan J. McCaughey, Angus J. McLachlan, Claire L. Boswell-Ruys, David W. Collins, Simon C. Gandevia, Armand R. J. Girbes, Oscar Hoiting, Matthijs Kox, Eline Oppersma, Marco Peters, Peter Pickkers, Lisanne H. Roesthuis, Jeroen Schouten, Zhong-Hua Shi, Peter H. Veltink, Heder J. de Vries, Cyndi Shannon Weickert, Carsten Wiedenbach, Yingrui Zhang, Pieter R. Tuinman, Angélique M. E. de Man, Jane E. Butler, Leo M. A. Heunks

Published in: Critical Care | Issue 1/2020

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Abstract

Background

Expiratory muscle weakness leads to difficult ventilator weaning. Maintaining their activity with functional electrical stimulation (FES) may improve outcome. We studied feasibility of breath-synchronized expiratory population muscle FES in a mixed ICU population (“Holland study”) and pooled data with our previous work (“Australian study”) to estimate potential clinical effects in a larger group.

Methods

Holland: Patients with a contractile response to FES received active or sham expiratory muscle FES (30 min, twice daily, 5 days/week until weaned). Main endpoints were feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety. Pooled: Data on respiratory muscle thickness and ventilation duration from the Holland and Australian studies were combined (N = 40) in order to estimate potential effect size. Plasma cytokines (day 0, 3) were analyzed to study the effects of FES on systemic inflammation.

Results

Holland: A total of 272 sessions were performed (active/sham: 169/103) in 20 patients (N = active/sham: 10/10) with a total treatment compliance rate of 91.1%. No FES-related serious adverse events were reported. Pooled: On day 3, there was a between-group difference (N = active/sham: 7/12) in total abdominal expiratory muscle thickness favoring the active group [treatment difference (95% confidence interval); 2.25 (0.34, 4.16) mm, P = 0.02] but not on day 5. Plasma cytokine levels indicated that early FES did not induce systemic inflammation. Using a survival analysis approach for the total study population, median ventilation duration and ICU length of stay were 10 versus 52 (P = 0.07), and 12 versus 54 (P = 0.03) days for the active versus sham group. Median ventilation duration of patients that were successfully extubated was 8.5 [5.6–12.2] versus 10.5 [5.3–25.6] days (P = 0.60) for the active (N = 16) versus sham (N = 10) group, and median ICU length of stay was 10.5 [8.0–14.5] versus 14.0 [9.0–19.5] days (P = 0.36) for those active (N = 16) versus sham (N = 8) patients that were extubated and discharged alive from the ICU. During ICU stay, 3/20 patients died in the active group versus 8/20 in the sham group (P = 0.16).

Conclusion

Expiratory muscle FES is feasible in selected ICU patients and might be a promising technique within a respiratory muscle-protective ventilation strategy. The next step is to study the effects on weaning and ventilator liberation outcome.
Trial registration: ClinicalTrials.gov, ID NCT03453944. Registered 05 March 2018—Retrospectively registered, https://​clinicaltrials.​gov/​ct2/​show/​NCT03453944.
Appendix
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Metadata
Title
Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis
Authors
Annemijn H. Jonkman
Tim Frenzel
Euan J. McCaughey
Angus J. McLachlan
Claire L. Boswell-Ruys
David W. Collins
Simon C. Gandevia
Armand R. J. Girbes
Oscar Hoiting
Matthijs Kox
Eline Oppersma
Marco Peters
Peter Pickkers
Lisanne H. Roesthuis
Jeroen Schouten
Zhong-Hua Shi
Peter H. Veltink
Heder J. de Vries
Cyndi Shannon Weickert
Carsten Wiedenbach
Yingrui Zhang
Pieter R. Tuinman
Angélique M. E. de Man
Jane E. Butler
Leo M. A. Heunks
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2020
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-020-03352-0

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