The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy (PhINEST)
Dysphagia
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Extubation, Intensive Care Unit, Pharyngeal Electrical Stimulation, Oropharyngeal Dysphagia, Mechanical Ventilation, Critically ill patients, Post-Extubation Dysphagia
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 bedside clinical assessment (within a maximum 8 hrs of extubation) according to 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,
- Presence of a permanent cardiac pacemaker and/or intracardiac defibrillator pacemaker,
- 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,
- 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.
Sites / Locations
- Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
- Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
- Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
- Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine
- Oulu University Hospital
- Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
- University Clinic for Intensive Medicine, InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active PES
Sham PES
Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter.
Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted.