Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized c
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Breath‑synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis Annemijn H. Jonkman1,2 , Tim Frenzel3, Euan J. McCaughey4,5, Angus J. McLachlan6, Claire L. Boswell‑Ruys4,5, David W. Collins7, Simon C. Gandevia4,5, Armand R. J. Girbes1,2, Oscar Hoiting8, Matthijs Kox3, Eline Oppersma9, Marco Peters8, Peter Pickkers3, Lisanne H. Roesthuis3, Jeroen Schouten3, Zhong‑Hua Shi1,2, Peter H. Veltink10, Heder J. de Vries1,2, Cyndi Shannon Weickert4,11,12, Carsten Wiedenbach8, Yingrui Zhang1, Pieter R. Tuinman1,2, Angélique M. E. de Man1,2, Jane E. Butler4,5 and Leo M. A. Heunks1,2*
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 (“Austral‑ ian 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 compli‑ ance, 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 thick‑ ness 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
*Correspondence: [email protected] 1 Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB Amsterdam, The Netherlands Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creati
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