The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy

NCT03840395 | Recruiting DMC

• 1 other identifier: AHE-06
• Study Type: interventional
• Target: 360
• Locations: 4 countries
• Sites: 7

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®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.

Conditions

Dysphagia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores

  Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities: Endpoint 1 - Swallowing safety based on worst PAS score in up to 4 thin (water) boli for each patient during FEES assessment converted to a trichotomised ordinal response of safe (PAS 1-3), penetration (PAS 4-5), or aspiration (PAS 6-8). The PAS provides a scoring system for airway closure and clearance during FEES. The PAS is a validated 8-point scale quantifying penetration and aspiration events primarily by the depth to which material passes into the airway and whether or not it is ejected.

  Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment

• Effectiveness of Phagenyx® treatment in reducing the severity of unsafe swallows - Dysphagia Outcome and Severity Score (DOSS) score

  Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities: Endpoint 2 - DOSS scale score determined by bedside assessment. The DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition. 1. Severe dysphagia 2. Moderately severe dysphagia 3. Moderate dysphagia 4. Mild-moderate dysphagia 5. Mild dysphagia 6. Functional limitation and modified independence 7. Normal in all situations

  7±1 days after the final Phagenyx® treatment

Secondary Outcomes (11)

• Effectiveness of Phagenyx® treatment in improving DOSS score.

  Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

• Effectiveness of Phagenyx® treatment on time from to feeding tube removal.

  Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

• Effectiveness of Phagenyx® treatment on time to oral intake.

  Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

• Effectiveness of Phagenyx® treatment on total days of enteral feeding.

  Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

• Effectiveness of Phagenyx® treatment in improving Functional Oral Intake Scale (FOIS) score.

  Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

Other Outcomes (10)

• Effectiveness of Phagenyx® treatment in reducing (dysphagia) secretion severity.

  Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment

• Effectiveness of Phagenyx® treatment in improving swallowing safety and efficiency - PAS scores

  Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment

• Effectiveness of Phagenyx® treatment in reducing bolus residue

  Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment

Study Arms (2)

Active PES

ACTIVE COMPARATOR

Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter.

Device: Pharyngeal Electrical Stimulation (PES)

Sham PES

SHAM COMPARATOR

Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted.

Device: Pharyngeal Electrical Stimulation (PES)

Interventions

Pharyngeal Electrical Stimulation (PES) DEVICE

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.

Also known as: Phagenyx

Active PES; Sham PES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,
• Participation in another interventional study (medicinal or device) that could influence the outcomes of PES,
• Treatment of dysphagia with other forms of electrical stimulation.

Sponsors & Collaborators

• Phagenesis Ltd.: lead
• NAMSA: collaborator
• Cytel Inc.: collaborator

Study Sites (7)

Medizinische Universität Innsbruck - Medizinische Universität Innsbruck

Innsbruck, 6020 INNSBRUCK, Austria

RECRUITING

Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin

Innsbruck, 6020 INNSBRUCK, Austria

RECRUITING

Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I

Innsbruck, 6020 INNSBRUCK, Austria

RECRUITING

Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine

Helsinki, 00029 HUS, Finland

WITHDRAWN

Oulu University Hospital

Oulu, 90220 OULU, Finland

WITHDRAWN

Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin

Hamburg, 20246 HAMBURG, Germany

RECRUITING

University Clinic for Intensive Medicine, Inselspital

Bern, CH-3010, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 32176093 BACKGROUND

• 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.

  PMID: 37924574 DERIVED

Related Links

• PhINEST Study - Protocol Manuscript

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Joerg Schefold, MD

  University Clinic for Intensive Medicine, Inselspital, University of Bern

  PRINCIPAL INVESTIGATOR

• Micheal Joannidis, MD

  Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I

  PRINCIPAL INVESTIGATOR

• Christopher Rugg, MD

  Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin

  PRINCIPAL INVESTIGATOR

• Alois Schiefecker, MD

  Medizinische Universität Innsbruck - Universitätsklinik für Neurologie

  PRINCIPAL INVESTIGATOR

• Stefan Kluge, MD

  Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish Mistry, PhD

CONTACT

+44 161 820 4525; clinical@phagenesis.com

Benaka Karanth

CONTACT

+44 1757 270044; bkaranth@namsa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: June 17, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); DE (1); AU (3); CH (1)