Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Diaphragm Thickening fraction
研究概览
简要总结
This study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients intubated and ventilated for at least 24 h
- •Patients who were expected to have at least 48h after inclusion
排除标准
- •Patient with pacemaker
- •Patient under neuro muscular blocker
- •Patient post thoracic or abdominal surgery
- •Patient with BMI more than 35 kg/m²
- •Patient with degenerative neurological pathology
- •Patient with cutaneous lesion may be interfered with probes
- •Patient with chronic loss of autonomy
- •Patient hospitalized more than 72 hours before ICU admission
- •Patient with severe chronic obstructive pulmonary disease (FEV1 < 30%)
- •Patient with decision to withhold life-sustaining treatment
研究组 & 干预措施
Sham Group
Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space.
Transcutaneous electrical stimulation settings: Frequency (2 hertz); wave length (300 µs);
干预措施: Sham electrical stimulation (Device)
Transcutaneous diaphragm electrical stimulation group
Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space.
Transcutaneous electrical stimulation settings: Frequency (35 hertz); wave length (300 µs); Intensity to achieve a visual contraction
干预措施: Transcutaneous diaphragm electrical stimulation (Device)
结局指标
主要结局
Diaphragm Thickening fraction
时间窗: Once, At the start of the spontaneous breathing trial
Diaphragm ultrasound was conducted using a 4-12-MHz linear array transducer. Diaphragm thickness was measured at end-expiration (Tdi,ee) and end inspiration (Tdi,ei), and thickening fraction (TFdi) was calculated offline as (Tdi,ei-Tdi,ee)/Tdi,ee.
次要结局
- Diaphragm atrophy(Once a day under mechanical ventilation, throughout the study)
- Inspiratory strength(Once, At the start of the spontaneous breathing trial)
- Cough strength(Once, At the start of the spontaneous breathing trial)
- Proportion of patients successfully liberated from the ventilator(After 3 days of spontaneous breathing)
研究者
Clément MEDRINAL
Principal Investigator
Groupe Hospitalier du Havre