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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
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 approa...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440171/ https://www.ncbi.nlm.nih.gov/pubmed/32176093 http://dx.doi.org/10.1097/MD.0000000000019503 |
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author | Schefold, Joerg C. Bäcklund, Minna Ala-Kokko, Tero Zuercher, Patrick Mukherjee, Rajat Mistry, Satish Mayer, Stephan A. Dziewas, Rainer Bakker, Jan Jakob, Stephan M. |
author_facet | Schefold, Joerg C. Bäcklund, Minna Ala-Kokko, Tero Zuercher, Patrick Mukherjee, Rajat Mistry, Satish Mayer, Stephan A. Dziewas, Rainer Bakker, Jan Jakob, Stephan M. |
author_sort | Schefold, Joerg C. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7440171 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-74401712020-09-04 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. Medicine (Baltimore) 3900 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. Wolters Kluwer Health 2020-03-13 /pmc/articles/PMC7440171/ /pubmed/32176093 http://dx.doi.org/10.1097/MD.0000000000019503 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 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 |
spellingShingle | 3900 Schefold, Joerg C. Bäcklund, Minna Ala-Kokko, Tero Zuercher, Patrick Mukherjee, Rajat Mistry, Satish Mayer, Stephan A. Dziewas, Rainer Bakker, Jan Jakob, Stephan M. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | phinest study – pharyngeal icu novel electrical stimulation therapy: study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study |
topic | 3900 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440171/ https://www.ncbi.nlm.nih.gov/pubmed/32176093 http://dx.doi.org/10.1097/MD.0000000000019503 |
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