StrokeNCT04010617
PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia
A study testing Pharyngeal Electrical Stimulation (PES) in people with Stroke and Dysphagia, run by University Hospital Muenster at 1 site in Germany.
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Dysphagia, Extubation Failure
- What is being tested?
- Pharyngeal Electrical Stimulation (PES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster, Deparment of Neurology
Münster, 48149
Rainer Dziewas, MD, +49251834 ext. 8239, dziewas@uni-muenster.de
Sonja Suntrup-Krueger, MD, +49251834 ext. 1127, sonja.suntrup-krueger@ukmuenster.de
About this study
Official title: Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia
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.
Read the detailed 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.
- Conditions
- Stroke, Dysphagia, Extubation Failure
- Being tested
- Pharyngeal Electrical Stimulation (PES)
- Keywords
- Pharyngeal Electrical Stimulation, Stroke, Dysphagia, Re-intubation
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | Orotracheal intubated patients at high risk of extubation failure will receive open-label PES Receives: Device: Pharyngeal Electrical Stimulation (PES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extubation
No re-intubation within 72 hours after extubation
Measured: 72 hours after extubation
Secondary outcomes (7)
Pneumonia
Pneumonia post extubation until hospital discharge
Measured: up to 14 days
Feeding status
Functional Oral Intake Scale
Measured: up to 14 days
Swallowing function
Fiberoptic Endoscopic Dysphagia Severity Scale
Measured: 0-24 hours after extubation
Swallowing function
Fiberoptic Endoscopic Dysphagia Severity Scale
Measured: 72-120 hours after extubation
Swallowing function
Fiberoptic Endoscopic Dysphagia Severity Scale
Measured: up to 14 days
Length of stay of the ICU/intermediate care
Length of stay in days
Measured: up to 60 days
Length of stay in hospital
Length of stay in hospital in days
Measured: up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jul 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational trial with comparison to a historical control group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Dziewas, MD, Principal investigator, Department of Neurology, University Hospital Münster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010617
- Sponsor's protocol ID
- 01072018
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: a subset of fully anonymised patient data may be available upon request from the authors
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia
- ClinicalTrials.gov ID
- NCT04010617
- Acronym / sponsor ID
- 01072018
- Conditions
- Stroke, Dysphagia, Extubation Failure
- Keywords
- Pharyngeal Electrical Stimulation, Stroke, Dysphagia, Re-intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational trial with comparison to a historical control group
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | Device: Pharyngeal Electrical Stimulation (PES)Orotracheal intubated patients at high risk of extubation failure will receive open-label PES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Pharyngeal Electrical Stimulation |
Primary outcome
Successful extubation
Time frame: 72 hours after extubation
No re-intubation within 72 hours after extubation
7 secondary outcomes
Pneumonia
Time frame: up to 14 days
Feeding status
Time frame: up to 14 days
Swallowing function
Time frame: 0-24 hours after extubation
Swallowing function
Time frame: 72-120 hours after extubation
Swallowing function
Time frame: up to 14 days
Length of stay of the ICU/intermediate care
Time frame: up to 60 days
Length of stay in hospital
Time frame: up to 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No. a subset of fully anonymised patient data may be available upon request from the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Dziewas, MD principal investigator
Department of Neurology, University Hospital Münster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Electrical Stimulation (PES) in people with Stroke and Dysphagia, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Dziewas, MD (+49251834 ext. 8239, dziewas@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful extubation (time frame: 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.