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

Stroke Clinical Trial

Official title:

Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010617
• Other study ID #: 01072018
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: University Hospital Muenster
• Contact: Rainer Dziewas, MD
• Phone: +49251834
• Email: dziewas[@]uni-muenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Endotracheal intubation and mechanical ventilation are common procedures for critically ill stroke patients. Although necessary and life-saving, timely extubation after ventilator weaning is desirable, because patients with delayed extubation experience higher pneumonia rate, increased need for tracheostomy, longer length of stay on the intensive care unit and higher mortality. On the other hand, extubation failure (EF) and subsequent need for emergent re-intubation is associated with similar sequelae.

Post-extubation dysphagia (PED) became a growing concern as a major risk factor for EF and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%). Damage to the central swallowing network itself is the primary cause of PED in cerebrovascular disease, which constitutes the leading diagnosis on neuro-ICUs. Further mechanisms include pharyngolaryngeal lesions caused by the tube, critical illness neuropathy and myopathy leading to muscle weakness and dyscoordination of breathing and swallowing, and an impaired sensation due to sedation, mucosal damage, or the underlying critical illness itself. As a consequence reintubation rates in neurological collectives are as high as 20 to 40%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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;

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Extubation Failure
• Stroke

Intervention

Device:
• Pharyngeal Electrical Stimulation (PES)
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.

Locations

Country	Name	City	State
Germany	University Hospital Münster, Deparment of Neurology	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful extubation	No re-intubation within 72 hours after extubation	72 hours after extubation
Secondary	Pneumonia	Pneumonia post extubation until hospital discharge	up to 14 days
Secondary	Feeding status	Functional Oral Intake Scale	up to 14 days
Secondary	Swallowing function	Fiberoptic Endoscopic Dysphagia Severity Scale	0-24 hours after extubation
Secondary	Swallowing function	Fiberoptic Endoscopic Dysphagia Severity Scale	72-120 hours after extubation
Secondary	Swallowing function	Fiberoptic Endoscopic Dysphagia Severity Scale	up to 14 days
Secondary	Length of stay of the ICU/intermediate care	Length of stay in days	up to 60 days
Secondary	Length of stay in hospital	Length of stay in hospital in days	up to 120 days