Pharyngeal electrical stimulation for treating swallowing difficulties after mechanical ventilation

The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy: a Prospective, Multi-site, Randomised, Sham-controlled, Single-blind (outcome Assessor-blinded) Study.

This study is testing if a device that uses electrical stimulation can help critically ill patients who have trouble swallowing after being on a ventilator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Phagenesis Ltd. (Industry-sponsored)
• Locations: 7 sites (Innsbruck and 6 other locations)
• Trial ID: NCT03840395 on ClinicalTrials.gov

What this trial studies

The PhINEST study evaluates the effectiveness of Pharyngeal Electrical Stimulation (PES) using the Phagenyx® device in treating oropharyngeal dysphagia in critically ill patients who have recently been extubated after mechanical ventilation. This multi-site, randomized, sham-controlled trial will assess outcomes related to swallowing safety and dysphagia severity through standardized assessments, including Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Patients will be randomly assigned to receive either the PES treatment or a sham treatment alongside standard ICU care. The study aims to enroll up to 360 patients, with interim analyses to guide sample size adjustments based on early results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have been recently extubated and diagnosed with post-extubation dysphagia.

Not a fit: Patients with severe agitation or sedation levels, or those who do not meet the dysphagia severity criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve swallowing safety and quality of life for patients recovering from mechanical ventilation.

How similar studies have performed: While the approach of using electrical stimulation for dysphagia treatment is promising, the specific application in this context is novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Innsbruck and 6 other locations

• Medizinische Universität Innsbruck - Medizinische Universität Innsbruck — Innsbruck, Austria (Recruiting)
• Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin — Innsbruck, Austria (Recruiting)
• Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I — Innsbruck, Austria (Recruiting)
• Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine — Helsinki, Finland (Withdrawn)
• Oulu University Hospital — Oulu, Finland (Withdrawn)
• Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin — Hamburg, Germany (Recruiting)
• University Clinic for Intensive Medicine, Inselspital — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Joerg Schefold, MD — University Clinic for Intensive Medicine, Inselspital, University of Bern
• Study coordinator: Satish Mistry, PhD

Conditions Dysphagia; Extubation; Intensive Care Unit; Pharyngeal Electrical Stimulation; Oropharyngeal Dysphagia; Mechanical Ventilation; Critically ill patients; Post-Extubation Dysphagia