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). 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, 99(11), e19503. Wolters Kluwer 10.1097/MD.0000000000019503
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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: DISCUSSION:: This study will evaluate the effects of PES on swallowing safety in critically ill ICU patients post mechanical ventilation with oropharyngeal dysphagia.
Item Type: |
Journal Article (Further Contribution) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care |
UniBE Contributor: |
Schefold, Jörg Christian, Zürcher, Patrick, Jakob, Stephan |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1536-5964 |
Publisher: |
Wolters Kluwer |
Language: |
English |
Submitter: |
Mirella Aeberhard |
Date Deposited: |
27 Mar 2020 10:45 |
Last Modified: |
05 Dec 2022 15:37 |
Publisher DOI: |
10.1097/MD.0000000000019503 |
PubMed ID: |
32176093 |
Additional Information: |
Contribution (LS, 26.2.2021) |
BORIS DOI: |
10.7892/boris.142021 |
URI: |
https://boris.unibe.ch/id/eprint/142021 |
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