Status:
RECRUITING
The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy
Lead Sponsor:
Phagenesis Ltd.
Collaborating Sponsors:
NAMSA
Cytel Inc.
Conditions:
Dysphagia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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®...
Detailed Description
The PhINEST study is designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any ...
Eligibility Criteria
Inclusion
- Pre-screening
- 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
- 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.
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03840395
Start Date
June 17 2019
End Date
December 1 2025
Last Update
November 12 2024
Active Locations (7)
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1
Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
Innsbruck, Austria, 6020 INNSBRUCK
2
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Innsbruck, Austria, 6020 INNSBRUCK
3
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Innsbruck, Austria, 6020 INNSBRUCK
4
Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine
Helsinki, Finland, 00029 HUS