PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia

NCT04010617 | Unknown

• 1 other identifier: 01072018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Post-extubation dysphagia (PED) recently became a growing concern as a major risk factor for extubation failure and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%). Pharyngeal electrical stimulation (PES) has been shown to improve airway safety and swallowing function tracheostomized stroke patients, thereby enhancing decannulation in this patient cohort. In the present study the investigators evaluate whether PES is safe, feasible and effective in orotracheal intubated stroke patients at high risk of extubation failure.

Conditions

Stroke; Dysphagia; Extubation Failure

Keywords

Pharyngeal Electrical Stimulation; Stroke; Dysphagia; Re-intubation

Outcome Measures

Primary Outcomes (1)

• Successful extubation

  No re-intubation within 72 hours after extubation

  72 hours after extubation

Secondary Outcomes (7)

• Pneumonia

  up to 14 days

• Feeding status

  up to 14 days

• Swallowing function

  0-24 hours after extubation

• Swallowing function

  72-120 hours after extubation

• Swallowing function

  up to 14 days

Study Arms (1)

Pharyngeal Electrical Stimulation

EXPERIMENTAL

Orotracheal intubated patients at high risk of extubation failure will receive open-label PES

Device: Pharyngeal Electrical Stimulation (PES)

Interventions

Pharyngeal Electrical Stimulation (PES) DEVICE

PES will be delivered by a commercial device (Phagenyx, Phagenesis Ltd, Manchester, UK), which comprises a nasogastric feeding catheter that houses stimulation ring-electrodes and a computerised base station that delivers stimulation in the range 1-50 mA at 5 Hz.

Pharyngeal Electrical Stimulation

Eligibility Criteria

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

You may qualify if:

• Acute stroke orotracheal intubation high-risk of extubation failure (DEFISS-score ≥4) successful respiratory weaning according to the treating intensivist within 24 to 72 hours

You may not qualify if:

• Patients are excluded from study participation if any of the following apply:
• Suffer from pre-existing neurogenic dysphagia or a condition that can cause dysphagia (for example Parkinson's Disease);
• Suffer from non-neurogenic dysphagia (e.g. cancer);
• Suffer from neuromuscular disorders (e.g. myasthenia gravis, motor neuron disease);
• Participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation;
• Receive or have received within one month prior to the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia;
• Have a pacemaker or an implantable defibrillator;
• Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe;
• Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe;
• Are pregnant or nursing women;

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster, Deparment of Neurology

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Rainer Dziewas, MD

  Department of Neurology, University Hospital Münster, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainer Dziewas, MD

CONTACT

+49251834; dziewas@uni-muenster.de

Sonja Suntrup-Krueger, MD

CONTACT

+49251834; sonja.suntrup-krueger@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational trial with comparison to a historical control group

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: July 8, 2019
• Study Start: July 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)