The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy
NCT ID: NCT03840395
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
360 participants
INTERVENTIONAL
2019-06-17
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia
NCT05190718
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
NCT03670485
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
NCT00213343
The Safety and Efficacy of the 4 Channel NMES on Swallowing
NCT03670498
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study
NCT05350150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main clinical outcomes assessing unsafe swallows and dysphagia severity will be measured using the gold standard, i.e. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and bedside swallowing assessments on day 2\* after completion of final PES treatment.
Randomisation will be on a 1:1 basis at each site stratified for neurological vs. non-neurological reason for admission (Acute Physiology and Chronic Health Evaluation (APACHE) IV diagnostic group). Patients will receive either PES/sham treatment in addition to standard supportive ICU care and standard of care treatments for dysphagia. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.
The study will follow an adaptive population enrichment and sample size re-estimation (SSR) design with one interim look. The study will start with a planned sample size of 200 patients and a maximum (evaluable) sample size of 360. Interim analysis after completion of approximately 140 (evaluable) patients will determine:
I. futility stopping; OR II. sample size increase for the overall sampled population; OR III. Enrichment based on the composite primary endpoint by pre-defined subgroups (neurological vs. non-neurological reason for admission according to APACHE IV diagnostic groups). Thus enrollment of patients in the non-performing sub-group will be stopped at the interim while a sample-size re-estimation based on conditional power will be carried out for the other sub-group.
All interim decisions will be based on conditional power which for the Finkelstein-Schoenfeld (FS)-statistic will need to be computed via Monte-Carlo simulations.
Up to thirty (30) investigational sites across Europe are planned to participate in this study which is expected to last 48 months from first patient first visit to last patient last visit. Patients will be assessed at the following intervals: screening, baseline, on day 2\* after completion of final study treatment, 7 ± 1 days after final study treatment and 14 ± 1 days after final study treatment (or hospital discharge if earlier). 30-day and 90-day mortality data will also be collected from the patients medical notes/electronic heath records/telephone call (no additional visit required).
\*The day two (FU1) visit is to be conducted on the second day (\~24hrs) following final PES treatment but may, under certain circumstances, be conducted upon/by the fourth day (\~60 hrs) following final study treatment in instances where the final study treatment is delivered on late Friday and where FEES assessment is only possible early on Monday as no weekend FEES service is available at the investigation site.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active PES
Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter.
Pharyngeal Electrical Stimulation (PES)
The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.
Sham PES
Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted.
Pharyngeal Electrical Stimulation (PES)
The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pharyngeal Electrical Stimulation (PES)
The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
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
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NAMSA
OTHER
Cytel Inc.
INDUSTRY
Phagenesis Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joerg Schefold, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic for Intensive Medicine, Inselspital, University of Bern
Micheal Joannidis, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Christopher Rugg, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Alois Schiefecker, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universität Innsbruck - Universitätsklinik für Neurologie
Stefan Kluge, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
Innsbruck, , Austria
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Innsbruck, , Austria
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Innsbruck, , Austria
Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine
Helsinki, , Finland
Oulu University Hospital
Oulu, , Finland
Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
Hamburg, , Germany
University Clinic for Intensive Medicine, Inselspital
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Schefold JC, Backlund M, Ala-Kokko T, Zuercher P, Mukherjee R, Mistry S, Mayer SA, Dziewas R, Bakker J, Jakob SM. The PhINEST study - Pharyngeal ICU Novel Electrical Stimulation Therapy: Study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study. Medicine (Baltimore). 2020 Mar;99(11):e19503. doi: 10.1097/MD.0000000000019503.
Likar R, Aroyo I, Bangert K, Degen B, Dziewas R, Galvan O, Grundschober MT, Kostenberger M, Muhle P, Schefold JC, Zuercher P. Management of swallowing disorders in ICU patients - A multinational expert opinion. J Crit Care. 2024 Feb;79:154447. doi: 10.1016/j.jcrc.2023.154447. Epub 2023 Nov 2.
Related Links
Access external resources that provide additional context or updates about the study.
PhINEST Study - Protocol Manuscript
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AHE-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.