Electric zaps to the throat aim to help ICU patients swallow again
NCT ID NCT03840395
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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72 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Dec 2025
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
Innsbruck, 6020 INNSBRUCK, Austria
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Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Innsbruck, 6020 INNSBRUCK, Austria
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Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Innsbruck, 6020 INNSBRUCK, Austria
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University Clinic for Intensive Medicine, Inselspital
Bern, CH-3010, Switzerland
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Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
Hamburg, 20246 HAMBURG, Germany
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Other studies related to the condition(s) this trial covers.
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