Transcutaneous Diaphragm Stimulation in ICU Patients

Karadeniz Technical University

Status

Not yet enrolling

Conditions

Intensive Care Patients

Treatments

Device: Transcutaneous Diaphragm Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06946251

2025/9

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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