Effect of Early Extracorporeal Diaphragm Pacing （EDP） Combined With Tilt Table Verticalization （TTV) on Diaphragm Function in Critically Ill Patients With Mechanical Ventilation: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7.
研究概览
简要总结
The aim of this study is to test the effect of 1week of extracorporeal diaphragm pacing (EDP) combined either with or without tilt table verticalization (TTV) on diaphragm function in patients with mechanical ventilation compared to conventional physiotherapy (CPT).
详细描述
In order to explore whether extracorporeal diaphragm pacing (EDP) combined with tilt table verticalization (TTV) improves diaphragm function in mechanically ventilated patients, the investigators conducted a three-arms randomized controlled trial of 90 ventilated patients in the ICU of a general hospital in the southern China state of Guangzhou. After assessment of inclusion and exclusion criteria, patients were randomly assigned to one of the following three groups: (1) EDP with TTV and with conventional physiotherapy (CPT) (n = 30), (2) EDP without TTV and with CPT (n = 30), and (3) conventional physiotherapy (CPT; n = 30).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of mechanical ventilation prior to enrollment≤ 72 hours.
- •Expected duration of mechanical ventilation≥72 hours.
- •Participants (or their legal representatives) have signed informed consent.
排除标准
- •Pregnancy or breast-feeding.
- •Prone ventilation or current extracorporeal membrane oxygenation.
- •Hemodynamic instability: mean arterial pressure is less than 65 millimeters of mercury (mmHg) or higher than 85 millimeters of mercury (mmHg), heart rate > 150 beats / minute, intravenous use of larger doses of vasopressors (such as dopamine > 10 mg/ (kg· min) or norepinephrine/epinephrine >0.1 mg/ (kg· min)) or aortic balloon counter pulsation; respiratory rate< 5 breaths per minute; Oxygen saturation< 88%.
- •New-onset myocardial ischemia.
- •Unstable cervical spine fracture and spinal cord injury.
- •Deterioration of neurological function, requiring intracranial pressure monitoring and ventricular drainage, or active control of intracranial hypertension.
- •Current neuromuscular block treatment or pre-existing neuromuscular disease or neuromuscular junction disease affecting respiratory muscle (such as myasthenia gravis, Guillain-Barré syndrome, etc.).
- •There are contraindications to diaphragmatic pacing (local skin, tissue incompleteness or infection, chest X-ray examination shows pneumothorax or pleural effusion accounting for 1/3 of bilateral chest cavity).
- •Body mass index (BMI) ⩾40 kg/m
- •Known / suspected phrenic nerve palsy.
- •Patients who refuse active treatment or are in the terminal stage of malignant tumors, have an expected life expectancy of < 6 months, etc.
- •Participated in other clinical studies related to mechanical ventilation within 2 months prior to the start of the study.
研究组 & 干预措施
Control group
In the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures.
干预措施: Conventional Physiotherapy (Other)
experimental group 1
the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group.
干预措施: Extracorporeal Diaphragm Pacing (Device)
experimental group 1
the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group.
干预措施: Conventional Physiotherapy (Other)
experimental group 2
the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
干预措施: Extracorporeal Diaphragm Pacing (Device)
experimental group 2
the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
干预措施: Tilt Table Verticalization (Device)
experimental group 2
the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7.
时间窗: Baseline, Day 4 and Day 7.
The Diaphragm thickening fraction-DTf (%) was calculated as the difference between end-expiration and end-inspiration divided by end-inspiration × 100.Diaphragm thickening fraction (DTf) less than 20% is a measure of ultrasonographic diaphragmatic dysfunction in patients on mechanical ventilation.
次要结局
- Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on minute ventilation at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on tidal volume at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on Blood oxygen status at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on Ventilation mode at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)
- Change from Baseline on MRC score at Day 4 and Day 7.(Baseline, Day 4 and Day 7.)