Transcutaneous Diaphragm Stimulation in ICU Patients

NCT06946251 | Not Yet Recruiting

• 1 other identifier: 2025/9
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intensive Care Patients

Keywords

Diaphragm Stimulation; Intensive care unit; Ejection Fraction

Outcome Measures

Primary Outcomes (4)

• Diaphragm Thickness and Thickening Fraction Measured by Ultrasound

  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

  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

  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

  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

Study Arms (4)

Group 1: Patients with low EF who receive TEDS

EXPERIMENTAL

Device: Transcutaneous Diaphragm Stimulation

Group 2: Patients with high EF who receive TEDS

EXPERIMENTAL

Device: Transcutaneous Diaphragm Stimulation

Group 3: Patients with low EF who do not receive TEDS

NO INTERVENTION

Group 4: Patients with high EF who do not receive TEDS

NO INTERVENTION

Interventions

Transcutaneous Diaphragm Stimulation DEVICE

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 1: Patients with low EF who receive TEDS; Group 2: Patients with high EF who receive TEDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 80 years
• Patients expected to require mechanical ventilation for at least 72 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 27, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04