Intensive Care Patients
Conditions
Keywords
Diaphragm Stimulation, Intensive care unit, Ejection Fraction
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.
Interventions
DEVICETranscutaneous 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.
Sponsors
Karadeniz Technical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm Thickness and Thickening Fraction Measured by Ultrasound | 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 | 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 | 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 | 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) |
Outcome results
None listed