Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Sham stimulation Device
    Intervention Desc: The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual patients. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.
    ARM 1: Kind: Experimental
    Label: Sham stimulation
    Description: Sham stimulation once daily for 10 minutes on three consecutive days.
  • Phagenyx-Catheter, Phagenesis Limited, UK. Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Pharyngeal electrical stimulation
    Description: Pharyngeal electrical stimulation once daily for 10 minutes on three consecutive days.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reintubation rate 120 hours No
Primary Pneumonia rate 120 hours No
Secondary Length of stay Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks No
Secondary Time until oral nutrition Participants will be followed for the duration of hospital stay, an expected average of 4 weeks No
Secondary PEG tube placement Participants will be followed for the duration of hospital stay, an expected average of 5 weeks. No
Secondary Swallowing function after 3 days of treatment No

Sponsors