Clinical trial NCT06946251: Transcutaneous Diaphragm Stimulation in ICU Patients
Official title: Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Patients
Keywords: Diaphragm Stimulation
Intensive care unit
Ejection Fraction
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
timeFrame: At baseline (Day 0) and on Day 5 of the study
measure: Duration of mechanical ventilation
timeFrame: At the beginning of the study and at the end of the 5-day period
measure: Length of stay in the intensive care unit
timeFrame: At the beginning of the study and at the end of the 5-day period
measure: Cardiac Function Parameters Assessed by Transthoracic Echocardiography
timeFrame: At baseline (Day 0) and on Day 5 of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: