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). 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 and 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:

27 Mar 2020 10:53

Publisher DOI:

10.1097/MD.0000000000019503

PubMed ID:

32176093

BORIS DOI:

10.7892/boris.142021

URI:

https://boris.unibe.ch/id/eprint/142021

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