Transcutaneous Diaphragm Stimulation in ICU Patients

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Diaphragm Thickness and Thickening Fraction Measured by Ultrasound [Срок оценки: At baseline (Day 0) and on Day 5 of the study]
• Duration of mechanical ventilation [Срок оценки: At the beginning of the study and at the end of the 5-day period]
• Length of stay in the intensive care unit [Срок оценки: At the beginning of the study and at the end of the 5-day period]
• Cardiac Function Parameters Assessed by Transthoracic Echocardiography [Срок оценки: At baseline (Day 0) and on Day 5 of the study]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06946251 · 2025/9

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗