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The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy (PhINEST)

Primary Purpose

Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pharyngeal Electrical Stimulation (PES)
Sponsored by
Phagenesis Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active PES

Sham PES

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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. Severe dysphagia Moderately severe dysphagia Moderate dysphagia Mild-moderate dysphagia Mild dysphagia Functional limitation and modified independence Normal in all situations

Secondary Outcome Measures

Effectiveness of Phagenyx® treatment in improving DOSS score.
Changes in nutritional management and severity of dysphagia as measured by the DOSS score.
Effectiveness of Phagenyx® treatment on time from to feeding tube removal.
Changes in nutritional management and severity of dysphagia as measured by time from randomisation to removal of feeding tube.
Effectiveness of Phagenyx® treatment on time to oral intake.
Changes in nutritional management and severity of dysphagia as measured by time to oral intake (if applicable).
Effectiveness of Phagenyx® treatment on total days of enteral feeding.
Changes in nutritional management and severity of dysphagia as measured by total days of enteral feeding.
Effectiveness of Phagenyx® treatment in improving Functional Oral Intake Scale (FOIS) score.
Changes in nutritional management and severity of dysphagia as measured by the FOIS score. The FOIS provides a scoring system to document the functional level of oral intake of food and liquid in patients with dysphagia. It is a validated 7-point ordinal scale easily completed from information contained in medical charts, dietary journals, and/or patient reports. Nothing by mouth Tube dependent with minimal attempts of food or liquid Tube dependent with consistent intake of liquid or food Total oral diet of a single consistency Total oral diet with multiple consistencies but requiring special preparation or compensations Total oral diet with multiple consistencies without special preparation, but with specific food limitations Total oral diet with no restriction
Effectiveness of Phagenyx® treatment in improving Dysphagia Severity Rating Scale (DSRS) score.
Changes in nutritional management and severity of dysphagia as measured by the DSRS score. The DSRS is a simple to use, validated 13-point scale composed of a 3-component score that includes feeding independence, but nutrition level and diet modification is split into the components of liquid feeding and overall diet consistency. The DSRS is the sum of the scores of each of the 3 individual components (range 0-4 for each component) rather than a combination of the three components into an ordinal scale. Best score = 0 (no dysphagia) Worst score = 12 (NPO)
Effectiveness of Phagenyx® treatment on time from extubation to ICU discharge
General health outcome measured by time from extubation to ICU discharge (days).
Effectiveness of Phagenyx® treatment on length of stay in ICU
General health outcome measured by length of stay in ICU (days).
Effectiveness of Phagenyx® treatment on length of stay in hospital.
General health outcome measured by length of stay in hospital (days).
Effectiveness of Phagenyx® treatment on number of patients with re-intubation during hospital stay
General health outcome measured by number of patients with re-intubation during hospital stay.
Effectiveness of Phagenyx® treatment on mortality
General health outcome measured by 30-day and 90-day mortality.

Full Information

First Posted
January 30, 2019
Last Updated
September 6, 2023
Sponsor
Phagenesis Ltd.
Collaborators
NAMSA, Cytel Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03840395
Brief Title
The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy
Acronym
PhINEST
Official Title
The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy: a Prospective, Multi-site, Randomised, Sham-controlled, Single-blind (Outcome Assessor-blinded) Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phagenesis Ltd.
Collaborators
NAMSA, Cytel Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia, Extubation, Intensive Care Unit, Pharyngeal Electrical Stimulation, Oropharyngeal Dysphagia, Mechanical Ventilation, Critically ill patients, Post-Extubation Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active PES
Arm Type
Active Comparator
Arm Description
Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter.
Arm Title
Sham PES
Arm Type
Sham Comparator
Arm Description
Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted.
Intervention Type
Device
Intervention Name(s)
Pharyngeal Electrical Stimulation (PES)
Other Intervention Name(s)
Phagenyx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores
Description
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.
Time Frame
Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment in reducing the severity of unsafe swallows - Dysphagia Outcome and Severity Score (DOSS) score
Description
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. Severe dysphagia Moderately severe dysphagia Moderate dysphagia Mild-moderate dysphagia Mild dysphagia Functional limitation and modified independence Normal in all situations
Time Frame
7±1 days after the final Phagenyx® treatment
Secondary Outcome Measure Information:
Title
Effectiveness of Phagenyx® treatment in improving DOSS score.
Description
Changes in nutritional management and severity of dysphagia as measured by the DOSS score.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on time from to feeding tube removal.
Description
Changes in nutritional management and severity of dysphagia as measured by time from randomisation to removal of feeding tube.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on time to oral intake.
Description
Changes in nutritional management and severity of dysphagia as measured by time to oral intake (if applicable).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on total days of enteral feeding.
Description
Changes in nutritional management and severity of dysphagia as measured by total days of enteral feeding.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment in improving Functional Oral Intake Scale (FOIS) score.
Description
Changes in nutritional management and severity of dysphagia as measured by the FOIS score. The FOIS provides a scoring system to document the functional level of oral intake of food and liquid in patients with dysphagia. It is a validated 7-point ordinal scale easily completed from information contained in medical charts, dietary journals, and/or patient reports. Nothing by mouth Tube dependent with minimal attempts of food or liquid Tube dependent with consistent intake of liquid or food Total oral diet of a single consistency Total oral diet with multiple consistencies but requiring special preparation or compensations Total oral diet with multiple consistencies without special preparation, but with specific food limitations Total oral diet with no restriction
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment in improving Dysphagia Severity Rating Scale (DSRS) score.
Description
Changes in nutritional management and severity of dysphagia as measured by the DSRS score. The DSRS is a simple to use, validated 13-point scale composed of a 3-component score that includes feeding independence, but nutrition level and diet modification is split into the components of liquid feeding and overall diet consistency. The DSRS is the sum of the scores of each of the 3 individual components (range 0-4 for each component) rather than a combination of the three components into an ordinal scale. Best score = 0 (no dysphagia) Worst score = 12 (NPO)
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on time from extubation to ICU discharge
Description
General health outcome measured by time from extubation to ICU discharge (days).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on length of stay in ICU
Description
General health outcome measured by length of stay in ICU (days).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on length of stay in hospital.
Description
General health outcome measured by length of stay in hospital (days).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on number of patients with re-intubation during hospital stay
Description
General health outcome measured by number of patients with re-intubation during hospital stay.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on mortality
Description
General health outcome measured by 30-day and 90-day mortality.
Time Frame
Up to 90 days after completion of the final Phagenyx® treatment.
Other Pre-specified Outcome Measures:
Title
Effectiveness of Phagenyx® treatment in reducing (dysphagia) secretion severity.
Description
Exploratory analysis of changes in secretion severity (severity of dysphagia) between FEES assessments measured by an Independent FEES Review Committee (IFRC) using the Murray Secretion Severity Rating Scale (SSS). The SSS is a simple, easy-to-use, 4-point scale that can systematically rate the graduation of accumulated secretions within the pharyngolarynx and trachea during FEES. 0. Normal Mild Moderate Severe
Time Frame
Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment in improving swallowing safety and efficiency - PAS scores
Description
Exploratory analysis of changes in swallowing safety and efficiency (severity of dysphagia) between FEES assessments measured by an IFRC based on worst PAS score for each bolus consistency (semi-solid and solid) for each patient during FEES assessment converted to a dichotomised ordinal response of non-aspirator (PAS 1-5) or aspirator (PAS 6-8).
Time Frame
Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment in reducing bolus residue
Description
Exploratory analysis of changes in bolus residue (severity of dysphagia) between FEES assessments measured by an IFRC using the Yale Pharyngeal Residue Severity Rating Scale (YRS). The YRS is a reliable, validated, anatomically defined, and image-based five-point ordinal rating scale to determine severity of post-swallow pharyngeal residue location (vallecula and pyriform sinus) and amount (i. none, ii. trace, iii. mild, iv. moderate, and v. severe) during FEES.
Time Frame
Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment in reducing global dysphagia severity
Description
Exploratory analysis of changes in severity of dysphagia between FEES assessments measured by an IFRC using the Global Dysphagia Severity Rating Scale (GDS). The GDS is a simple, easy-to-use, 4-point scale developed to systematically rate the severity of dysphagia during FEES. 0. No relevant dysphagia Mild dysphagia: Premature spillage and/or residues, but no penetration/aspiration events. Moderate dysphagia: Penetration/aspiration events with one consistency. Severe dysphagia: Penetration/aspiration events with two or more consistencies.
Time Frame
Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment on time from extubation to hospital discharge
Description
Exploratory analysis of general health outcome measured by time from extubation to hospital discharge (days).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on days on antimicrobials post-extubation (while in ICU)
Description
Exploratory analysis of general health outcome measured by days on antimicrobials post-extubation (while in ICU).
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on hospital discharge destination
Description
Exploratory analysis of general health outcome measured by hospital discharge destination (home, home+care, nursing home, other hospital, rehabilitation centre).
Time Frame
Up to 90 days after the final Phagenyx® treatment
Title
Effectiveness of Phagenyx® treatment on ICU readmission rate during hospital stay
Description
Exploratory analysis of general health outcome measured by ICU readmission rate during hospital stay.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on tracheostomies per subgroup
Description
Exploratory analysis of general health outcome measured by number of and reason for tracheostomies per subgroup after PES-treatment during hospital stay.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Title
Effectiveness of Phagenyx® treatment on chest X-rays for suspected pneumonia.
Description
Exploratory analysis of general health outcome measured by total number of chest X-rays during hospital stay after ICU discharge for suspected pneumonia.
Time Frame
Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satish Mistry, PhD
Phone
+44 161 820 4525
Email
clinical@phagenesis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Benaka Karanth
Phone
+44 1757 270044
Email
bkaranth@namsa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Schefold, MD
Organizational Affiliation
University Clinic for Intensive Medicine, Inselspital, University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Micheal Joannidis, MD
Organizational Affiliation
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Rugg, MD
Organizational Affiliation
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alois Schiefecker, MD
Organizational Affiliation
Medizinische Universität Innsbruck - Universitätsklinik für Neurologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Kluge, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020 INNSBRUCK
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alois Schiefecker, MD
Email
alois.schiefecker@tirol-kliniken.at
Facility Name
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
City
Innsbruck
ZIP/Postal Code
6020 INNSBRUCK
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Rugg
Email
christopher.rugg@tirol-kliniken.at
Facility Name
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
City
Innsbruck
ZIP/Postal Code
6020 INNSBRUCK
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micheal Joannidis, MD
Email
michael.joannidis@tirol-kliniken.at
Facility Name
Helsinki University Hospital Perioperative, Intensive Care and Pain Medicine
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220 OULU
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
City
Hamburg
ZIP/Postal Code
20246 HAMBURG
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UKE KIM-Studienzentrale
Email
kim-studienzentrale@uke.de
Facility Name
University Clinic for Intensive Medicine, Inselspital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg C Schefold, MD
Email
Joerg.Schefold@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32176093
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32176093/
Description
PhINEST Study - Protocol Manuscript

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The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy

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