Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT03840395
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03840395
Study Brief:
Protocol Section:
NCT03840395