The PhINEST study – Pharyngeal ICU Novel Electrical Stimulation Therapy : study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study
Schefold, Joerg C.; Bäcklund, Minna; Ala-Kokko, Tero; Zuercher, Patrick; Mukherjee, Rajat; Mistry, Satish; Mayer, Stephan A.; Dziewas, Rainer; Bakker, Jan; Jakob, Stephan M. (2020-03-01)
Schefold JC, Bäcklund M, Ala-Kokko T, Zuercher P, Mukherjee R, Mistry S, Mayer SA, Dziewas R, Bakker J, Jakob SM. The PhINEST study – Pharyngeal ICU Novel Electrical Stimulation Therapy: study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study. Medicine 2020;99:11(e19503). https://doi.org/10.1097/MD.0000000000019503
© 2020 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
https://creativecommons.org/licenses/by/4.0/
https://urn.fi/URN:NBN:fi-fe2020050424843
Tiivistelmä
Abstract
Introduction: Post-extubation dysphagia is commonly observed in ICU patients and associated with increased aspiration rates, delayed resumption of oral intake/ malnutrition, prolonged ICU and hospital length of stay, decreased quality of life, and increased mortality. Conventional therapeutic approaches are limited. Pharyngeal electrical stimulation (PES) was previously shown to improve swallowing function and airway safety in severely dysphagic tracheostomised stroke patients.
Methods: In a multi-center, single-blind, 1:1 randomized controlled study, up to 400 (360 evaluable) mixed emergency adult ICU patients with recent extubation following mechanical ventilation and confirmed oropharyngeal dysphagia will be enrolled at investigational academic ICUs. Primary objective is to evaluate the effectiveness of PES in reducing the severity of unsafe swallows. Patients will be randomized to receive PES (or sham) treatment on 3 consecutive days in addition to best supportive care. Primary endpoint is a composite of 2 endpoints with hierarchy based on clinical priorities:
1) Swallowing safety based on worst penetration-aspiration-scale (PAS) score in series of up to 4 boli using thin stimuli approx. From 24 to 60 hours after treatment completion, converted to a trichotomized ordinal response of safe (PAS 1–3), penetration (PAS 4–5), or aspiration (PAS 6–8).
2) Dysphagia Outcome and Severity Scale scores determined by bedside assessment 7 ± 1 days after treatment completion. Oropharyngeal dysphagia will be assessed by Fiberoptic Endoscopic Evaluation of Swallowing by blinded study staff. Patients will be followed-up for a maximum of 90 days.
Discussion: This study will evaluate the effects of PES on swallowing safety in critically ill ICU patients post mechanical ventilation with oropharyngeal dysphagia.
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