NCT02470078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

June 3, 2015

Last Update Submit

February 5, 2020

Conditions

StrokeDysphagia

Keywords

extubation

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Length of stay

    Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks

  • Time until oral nutrition

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • PEG tube placement

    Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.

  • Swallowing function

    after 3 days of treatment

Study Arms (2)

Pharyngeal electrical stimulation

EXPERIMENTAL

Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.

Device: Phagenyx-Catheter, Phagenesis Limited, UK.

Sham stimulation

SHAM COMPARATOR

Sham stimulation once daily for 10 minutes on three consecutive days.

Device: Sham stimulation

Interventions

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.

Pharyngeal electrical stimulation
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.

Sham stimulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- severe dysphagia post extubation due to acute stroke

You may not qualify if:

  • preexisting dysphagia
  • comorbidities that can possibly cause dysphagia
  • psychiatric comorbidities
  • pacemaker or other implanted electronic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University of Muenster

Münster, 48129, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37789340DERIVED

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Rainer Dziewas, MD

    University Hospital Münster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 12, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

DE(1)