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Impact of Electrical Stimulation Therapy on Post-Extubation Dysphagia during Mechanical Ventilation

Impact of Electrical Stimulation Therapy on Post-Extubation Dysphagia during Mechanical Ventilation: A Pilot & Feasibility Single-Center Randomized Trial - PED-EMV Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062240054
Enrollment
40
Registered
2024-09-13
Start date
2025-11-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post extubation dysphagia

Interventions

Electrical Stimulation Therapy: IFC-TESS Procedure: Attach the IFC-TESS electrodes to the pharynx and perform the therapy for 0.5 hours per session, twice a day. The output level should be set at 2.5
Electric Stimulation Therapy

Sponsors

Hongo Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older 2.Patients admitted to the EICU who are expected to require mechanical ventilation for more than 48 hours and be extubated

Exclusion criteria

Exclusion criteria: 1.Patients who did not experience limited oral intake before admission (i.e., patients on enteral nutrition or parenteral nutrition) 2.Patients admitted to the EICU due to seizure 3.Patients with dementia who could not follow instructions before EICU admission 4.Patients with a tracheostomy before EICU admission 5.Patients who received speech and language therapy before EICU admission 6.Patients readmitted to the EICU 7.Patients in the EICU after gastrointestinal surgery who are expected to fast for a long period 8.Patients in the EICU after neck surgery 9.Patients with severe facial trauma are expected to require a tracheostomy 10.Patients with an ICD or pacemaker 11.Patients transferred from other institutions more than 24 hours after intubation 12.Pregnant or postpartum women 13.Patients deemed unsuitable for the study by the principal investigator or co-investigators 14.Patients who do not consent to participate

Design outcomes

Primary

MeasureTime frame
The proportions of patients with under 3 scores of modified water swallowing test on the day of extubation.

Secondary

MeasureTime frame
1.Survival period 2.Adverse events(pain, skin injury, discomfort, agitation, non-cooperation, and change in vital signs or RASS) 3.Pepsin, salivary amylase, and presence of hoarseness at the time of extubation 4.MWST (scores, proportions of participants who achieved 5 points), RSST, RASS, CAM-ICU, and presence of hoarseness on the day of extubation 5.FOIS on days 1-7 post-extubation 6.Number of days with oral intake restrictions (FOIS < 5, < 7) within the first 7 days post-extubation 7.Days achieving scores of 7 and 5 on the 7-point FOIS scale 8.Length of EICU stay, ICU mortality, and outcomes (discharge to home, general hospital, rehabilitation hospital, nursing facility, death, other) 9.Incidence of complications (ventilator-associated pneumonia, aspiration pneumonia) after enrollment during EICU stay 10.Incidence of tracheostomy after enrollment during EICU stay 11.Incidence and duration of delirium after enrollment during EICU stay 12.Incidence of reintubation and days from extubation to reintubation after enrollment during EICU stay 13.Frailty (Clinical Frailty Scale) at the time of EICU discharge 14.Barthel Index and IMS at the time of EICU discharge 15.Quality of life (EQ-5D-5L) at the time of EICU discharge 16.Cognitive function (Mini-Mental State Examination [MMSE]) at the time of EICU discharge 17.Mental function (Hospital Anxiety and Depression Scale [HADS]) at the time of EICU discharge If the above questionnaires cannot be completed at the time of ICU discharge, provide the reason (e.g., impaired consciousness) 18.Duration of intubation

Contacts

Public ContactTakashi Hongo

Okayama University Hospital

taka.hongo123@gmail.com+81-86-235-7427

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026