StrokeNCT02470078
Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke
A study testing Phagenyx-Catheter, Phagenesis Limited, UK. in people with Stroke and Dysphagia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Phagenyx-Catheter, Phagenesis Limited, UK.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Sep 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe dysphagia post extubation due to acute stroke
Who cannot join
- preexisting dysphagia
- comorbidities that can possibly cause dysphagia
- psychiatric comorbidities
- pacemaker or other implanted electronic devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients
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.
- Being tested
- Phagenyx-Catheter, Phagenesis Limited, UK., Sham stimulation
- Keywords
- extubation
- 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.
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.
Sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal electrical stimulation | Experimental | Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days. Receives: Device: Phagenyx-Catheter, Phagenesis Limited, UK. |
| Sham stimulation | Sham comparator | Sham stimulation once daily for 10 minutes on three consecutive days. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rate
Need for reintubation within 120 hours from extubation
Measured: 120 hours
Pneumonia rate
Incidence of aspiration pneumonia within 120 hours from extubation
Measured: 120 hours
Secondary outcomes (4)
Length of stay
Length of stay on the intensive care unit
Measured: Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks
Time until oral nutrition
Time span from extubation until consumption of an completely oral diet is safely possible
Measured: 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
Measured: 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
Measured: after 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Dziewas, MD, Principal investigator, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470078
- Sponsor's protocol ID
- 2014-155
- Status last verified
- Feb 2020
- First submitted
- 3 Jun 2015
- Last updated
- 7 Feb 2020
- Results posted
- No
Publications
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.
PubMed 37789340
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT02470078
- Acronym / sponsor ID
- 2014-155
- Keywords
- extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal electrical stimulation | Experimental | Device: Phagenyx-Catheter, Phagenesis Limited, UK.Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days. |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham stimulation once daily for 10 minutes on three consecutive days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe dysphagia post extubation due to acute stroke
Key exclusion criteria (4 listed)
- preexisting dysphagia
- comorbidities that can possibly cause dysphagia
- psychiatric comorbidities
- pacemaker or other implanted electronic devices
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 |
|---|---|---|
| Phagenyx-Catheter, Phagenesis Limited, UK.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. | Device | Pharyngeal electrical stimulation |
| Sham stimulationThe 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. | Device | Sham stimulation |
Primary outcome
Reintubation rate
Time frame: 120 hours
Need for reintubation within 120 hours from extubation
Pneumonia rate
Time frame: 120 hours
Incidence of aspiration pneumonia within 120 hours from extubation
4 secondary outcomes
Length of stay
Time frame: Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks
Time until oral nutrition
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
PEG tube placement
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.
Swallowing function
Time frame: after 3 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 37789340Suntrup-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.
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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
University Hospital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phagenyx-Catheter, Phagenesis Limited, UK. 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 4 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: finished, as of the sponsor's last update on 7 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation rate (time frame: 120 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470078, which also lists 1 linked publication.
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 7 Feb 2020.