Electric zaps to the throat aim to help ICU patients swallow again

NCT ID NCT03840395

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that sends mild electrical pulses to the throat to help ICU patients who have trouble swallowing after being on a breathing machine. The goal was to see if it could reduce the risk of food or liquid going into the lungs. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

72 people

The number who actually took part.

Started

Jun 2019

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 rupture) where the placement of a standard nasogastric feeding tube (NGT) would be deemed unsafe, * Cardiac or respiratory condition that might render the insertion (placement) of a catheter into the throat unsafe, * Permanently implanted electrical devices, * Are pregnant (pregnancy test) or known lactating women, * Have non-neurogenic dysphagia (e.g. Cancer-related), * Any prior tracheostomy, * Patients who at the time of extubation have any treatment limitation (i.e., palliative care, life expectancy less than 48 hours, or are moribund), that prevents or would prevent compliance with study-specific instructions or procedures (as judged by the investigator), * Severe cognitive impairment or other reasons that prevents compliance with study-specific instructions or procedures (as judged by the investigator), * Previous history of dysphagia of any origin, * Pre-existing tube feeding of any form (e.g. percutaneous gastric/enteral feeding tube related to previous injuries indicating previous dysphagia. NGTs are not an exclusion criterion), * Participation in another interventional study (medicinal or device) that could influence the outcomes of PES, * Treatment of dysphagia with other forms of electrical stimulation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dysphagia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Deglutition Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medizinische Universität Innsbruck - Medizinische Universität Innsbruck

    Innsbruck, 6020 INNSBRUCK, Austria

  • Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin

    Innsbruck, 6020 INNSBRUCK, Austria

  • Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I

    Innsbruck, 6020 INNSBRUCK, Austria

  • University Clinic for Intensive Medicine, Inselspital

    Bern, CH-3010, Switzerland

  • Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin

    Hamburg, 20246 HAMBURG, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.