Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharyngeal electrical stimulation | Experimental | Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days. |
|
| Sham stimulation | Sham Comparator | Sham stimulation once daily for 10 minutes on three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phagenyx-Catheter, Phagenesis Limited, UK. | Device | Pharyngeal electrical stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered. |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation rate | Need for reintubation within 120 hours from extubation | 120 hours |
| Pneumonia rate | Incidence of aspiration pneumonia within 120 hours from extubation | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Length of stay on the intensive care unit | Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks |
| Time until oral nutrition |
Not provided
Inclusion Criteria:
- severe dysphagia post extubation due to acute stroke
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rainer Dziewas, MD | University Hospital Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Muenster | Münster | 48129 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37789340 | Derived | Suntrup-Krueger S, Labeit B, Marian T, Schroder J, Claus I, Ahring S, Warnecke T, Dziewas R, Muhle P. Pharyngeal electrical stimulation for postextubation dysphagia in acute stroke: a randomized controlled pilot trial. Crit Care. 2023 Oct 3;27(1):383. doi: 10.1186/s13054-023-04665-6. No abstract available. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham stimulation | Device | The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered. |
|
Time span from extubation until consumption of an completely oral diet is safely possible
| Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| PEG tube placement | Number of participants needing percutaneous endogastric tube placement due to persistent severe dysphagia | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks. |
| Swallowing function | Salient semiquantitative parameters of swallowing function (leaking, penetration, aspiration, residues, delayed triggering of swallow reflex) as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment | after 3 days of treatment |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |