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.
Condition or disease | Intervention/treatment | Phase |
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Stroke Dysphagia Extubation Failure | Device: Pharyngeal Electrical Stimulation (PES) | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Observational trial with comparison to a historical control group |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | November 1, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Experimental: Pharyngeal Electrical Stimulation
Orotracheal intubated patients at high risk of extubation failure will receive open-label PES
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
Contact: Rainer Dziewas, MD | +49251834 ext 8239 | dziewas@uni-muenster.de | |
Contact: Sonja Suntrup-Krueger, MD | +49251834 ext 1127 | sonja.suntrup-krueger@ukmuenster.de |
Germany | |
University Hospital Münster, Deparment of Neurology | Recruiting |
Münster, Germany, 48149 | |
Contact: Rainer Dziewas, MD +49251834 ext 8239 dziewas@uni-muenster.de | |
Contact: Sonja Suntrup-Krueger, MD +49251834 ext 1127 sonja.suntrup-krueger@ukmuenster.de |
Principal Investigator: | Rainer Dziewas, MD | Department of Neurology, University Hospital Münster, Germany |
Tracking Information | |||||
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First Submitted Date ICMJE | May 29, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | July 8, 2019 | ||||
Actual Study Start Date ICMJE | July 1, 2018 | ||||
Estimated Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Successful extubation [ Time Frame: 72 hours after extubation ] No re-intubation within 72 hours after extubation
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia | ||||
Official Title ICMJE | Pharyngeal Electrical Stimulation (PES) to Avoid Extubation Failure in Intubated Stroke at High Risk of Severe Dysphagia | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Observational trial with comparison to a historical control group Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | Experimental: Pharyngeal Electrical Stimulation
Orotracheal intubated patients at high risk of extubation failure will receive open-label PES
Intervention: Device: Pharyngeal Electrical Stimulation (PES)
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04010617 | ||||
Other Study ID Numbers ICMJE | 01072018 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Hospital Muenster | ||||
Study Sponsor ICMJE | University Hospital Muenster | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University Hospital Muenster | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |