Transcutaneous Diaphragm Stimulation in ICU Patients
Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation
The aim of this study is to compare the effects of transcutaneous electrical diaphragm stimulation (TEDS) on diaphragm thickness, duration of mechanical ventilation, length of ICU stay, and right/left heart functions between patient groups with low and high ejection fraction (EF) levels.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 80 years
- Patients expected to require mechanical ventilation for at least 72 hours
Exclusion Criteria:
- Presence of known neuromuscular diseases that contraindicate the use of transcutaneous diaphragm stimulation
- Phrenic nerve injury
- History of abdominal or thoracic surgery that prevents the application of diaphragm stimulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Patients with low EF who receive TEDS
|
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. |
|
Experimental: Group 2: Patients with high EF who receive TEDS
|
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. |
|
No Intervention: Group 3: Patients with low EF who do not receive TEDS
|
|
|
No Intervention: Group 4: Patients with high EF who do not receive TEDS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
Time Frame: At baseline (Day 0) and on Day 5 of the study
|
Diaphragm thickness will be measured using B-mode ultrasonography. The following parameters will be assessed: Diaphragm thickness at end-expiration (Tdi-exp), in millimeters (mm) Diaphragm thickness at end-inspiration (Tdi-insp), in millimeters (mm) Diaphragm thickening fraction (TF), calculated using the following formula: TF = (Tdi-insp - Tdi-exp) / Tdi-exp × 100. |
At baseline (Day 0) and on Day 5 of the study
|
|
Duration of mechanical ventilation
Time Frame: At the beginning of the study and at the end of the 5-day period
|
Length of ICU stay will be recorded in days for each patient during the 5-day study follow-up.
The duration will be calculated from the date and time of ICU admission until discharge or the end of the 5-day observation period, whichever comes first.
Data will be obtained from patient medical records.
|
At the beginning of the study and at the end of the 5-day period
|
|
Length of stay in the intensive care unit
Time Frame: At the beginning of the study and at the end of the 5-day period
|
The total number of days each patient remains in the intensive care unit (ICU) will be recorded during the 5-day follow-up period.
ICU stay duration will be calculated from the time of ICU admission until ICU discharge or the end of the 5-day observation period, whichever occurs first.
Data will be obtained from patient medical records.
|
At the beginning of the study and at the end of the 5-day period
|
|
Cardiac Function Parameters Assessed by Transthoracic Echocardiography
Time Frame: At baseline (Day 0) and on Day 5 of the study
|
Cardiac function will be assessed using transthoracic echocardiography (TTE) performed by an experienced cardiologist. The following echocardiographic parameters will be recorded to evaluate both systolic and diastolic cardiac function: E/A ratio (m/s) e' velocity (cm/s) E/e' ratio Pulmonary vein flow pattern Peak flow velocity (m/s) Left atrial volume index (mL/m²) Left ventricular ejection fraction (LVEF, %) Right atrial volume (mL) Right ventricular volume (mL) Pulse Doppler myocardial performance index (RIMP) Tissue Doppler myocardial performance index (RIMP) Fractional area change (FAC, %) Tricuspid annular plane systolic excursion (TAPSE, cm) Tissue Doppler S wave velocity (cm/s) |
At baseline (Day 0) and on Day 5 of the study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/9
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.