Transcutaneous Diaphragm Stimulation in ICU Patients

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.

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Key information

Conditions

Intensive Care Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Diaphragm Stimulation

Device

Primary outcomes

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.
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.
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.
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)

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 27, 2025
Registry last updated: Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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