Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years
- •Patients expected to require mechanical ventilation for at least 72 hours
排除标准
- •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
研究组 & 干预措施
Group 4: Patients with high EF who do not receive TEDS
Group 1: Patients with low EF who receive TEDS
干预措施: Transcutaneous Diaphragm Stimulation (Device)
Group 2: Patients with high EF who receive TEDS
干预措施: Transcutaneous Diaphragm Stimulation (Device)
Group 3: Patients with low EF who do not receive TEDS
结局指标
主要结局
Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
A. Oguzhan KUCUK
MD
Karadeniz Technical University