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

JRCT ID: jRCTs062240054

Registered date:13/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Post extubation dysphagia
• Date of first enrollment: 13/09/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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 mA.

Setup
Wipe off any dirt from the anterior neck with a towel or similar. Place the electrode along the jaw at a position 4.0 cm away from the edge of the thyroid cartilage and the electrode on the same side. The principal investigator, co-investigator, or physician will perform the initiation of electrical stimulation.

SpO2 less than 90% before starting electrical stimulation therapy or during the therapy
Systolic blood pressure less than 70 mmHg or more than 200mmHg
Pulse rate less than 40 beats per minute or more than 180 beats per minute
If the attending physician deems it inappropriate
If there are tests or treatments at the time of electrical stimulation therapy making it physically difficult to perform the therapy

Outcome(s)

• Primary Outcome: The proportions of patients with under 3 scores of modified water swallowing test on the day of extubation.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hongo Takashi
• Source(s) of Monetary Support: Japan Society for the Promotion of Science