Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
76 participants
INTERVENTIONAL
2025-05-31
2026-05-31
Brief Summary
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This randomized controlled trial will record demographic data, diaphragm ultrasound measurements, and echocardiographic findings of patients who receive or do not receive TEDS for five consecutive days.
Participants will be divided into four groups according to their EF levels and whether or not they receive diaphragm stimulation:
Group 1: Patients with low EF who receive TEDS Group 2: Patients with high EF who receive TEDS Group 3: Patients with low EF who do not receive TEDS Group 4: Patients with high EF who do not receive TEDS
Diaphragm thickness and echocardiographic assessments will be performed at baseline and at the end of the five-day TEDS intervention.
TEDS Application Protocol
In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.
A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.
Electrode placement involves:
The first pair of electrodes placed bilaterally between the 8th and 10th anterior intercostal spaces, lateral to the xiphoid process.
The second pair placed along the mid-axillary line of the thorax, also between the 8th and 10th intercostal spaces.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Patients with low EF who receive TEDS
Transcutaneous Diaphragm Stimulation
In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.
A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.
Group 2: Patients with high EF who receive TEDS
Transcutaneous Diaphragm Stimulation
In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.
A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.
Group 3: Patients with low EF who do not receive TEDS
No interventions assigned to this group
Group 4: Patients with high EF who do not receive TEDS
No interventions assigned to this group
Interventions
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Transcutaneous Diaphragm Stimulation
In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.
A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.
Eligibility Criteria
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Inclusion Criteria
* Patients expected to require mechanical ventilation for at least 72 hours
Exclusion Criteria
* Phrenic nerve injury
* History of abdominal or thoracic surgery that prevents the application of diaphragm stimulation
18 Years
80 Years
ALL
No
Sponsors
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Karadeniz Technical University
OTHER
Responsible Party
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A. Oguzhan KUCUK
MD
Other Identifiers
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2025/9
Identifier Type: -
Identifier Source: org_study_id
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