TerminatedNot Applicable

The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy

Stopped: Recruitment difficulties

Austria, Germany, Switzerland72 participantsStarted 2019-06-17

Plain-language summary

This is a prospective, multi-site, randomised, sham-controlled, single-blind (outcome assessor-blinded) study designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Pre-screening Inclusion Criteria: All of the following criteria must be met for inclusion: * Age ≥ 18 ≤ 85, * Emergency ICU admission (unplanned admission), * Recent extubation following invasive mechanical ventilation (of any length of time) by means of endotracheal tube, * Presence of post-extubation dysphagia as determined by the participating Sites' Standard Of Care (SOC). Screening / Enrolment Criteria: To be eligible for enrolment in this study, an individual must meet all of the following additional criteria: * Presence of written informed consent according to respective national guidelines, * Dysphagia severity status classified according to PAS on FEES assessment as 'aspiration' (PAS score ≥ 6), * Richmond Agitation and Sedation Scale (RASS) score within the range of -1 to +2 (i.e. if score equals -2, -3, -4 or +3, +4, patient is excluded). Randomisation Inclusion Criteria (post-consent) The following additional criteria must be met for randomisation: • Successful placement and subjective tolerance of the Phagenyx® Catheter within 2 days of extubation.(post consent) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from enrolment in this study: * Nasal anatomical deformity, nasal airway obstruction; patient who have had recent oral, nasal or oesophageal surgery or patient presenting with facial and/or cranial fractures or any other circumstance (e.g. history of oesophageal perforation, stricture, pouch, resection or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores

Timeframe: Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment

Effectiveness of Phagenyx® treatment in reducing the severity of unsafe swallows - Dysphagia Outcome and Severity Score (DOSS) score

Timeframe: 7±1 days after the final Phagenyx® treatment

Trial details

NCT IDNCT03840395

SponsorPhagenesis Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Dysphagia trials