Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Ventilator-free days
研究概览
简要总结
the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.
详细描述
A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.
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
- Single (Participant)
盲法说明
Patients enrolled in the study were unaware of the study
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
- •Age ≥18years and ≤80years;
- •MV time ≤48h;
- •MV duration is expected to be ≥72h;
- •The sternocleidomastoid region and pectoralis major region were completely exposed.
- •Patients or family members are willing to sign informed consent and participate in the study.
排除标准
- •There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
- •Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
- •ECMO status;
- •Hemodynamic instability;
- •Uncorrected arrhythmias;
- •Be pregnant;
- •Clinical end-stage and palliative care patients.
研究组 & 干预措施
conventional group
- conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training.
- No intervention
PNS group
In addition to conventional respiratory therapy and pulmonary rehabilitation, neuromuscular electrical stimulator was used for PNS
- Device Settings Strength: Maximum current tolerated by the patient (0-100mA, commonly used below 13mA) ； Stimulation time: 1.0s; Frequency: 40Hz;
- Location: The stimulation electrodes were attached to the left and right sides of the neck under the outer margin of the sternocleidomastoid muscle 1/3; The reference electrodes were attached to the surface of both pectoralis major muscles.
- Treatment frequency: 30 at a time, Bid, until withdrawal/death/for 4 weeks.
干预措施: Non-invasive phrenic nerve stimulation (Device)
结局指标
主要结局
Ventilator-free days
时间窗: 28 days
次要结局
- Transdiaphragmatic Pressure(up to 28 days)
- re-intubation rate(28 days)
- ICU mortality(28 days)
- diaphragm thickening fraction(up to 28 days)
- Diaphragm thickness(up to 28 days)
- mechanical ventilation days(28 days)
- Maximal Inspiratory Pressure(up to 28 days)
- 60/90-day survival rate(28 days)
研究者
Bing Sun
professor of treatment
Beijing Chao Yang Hospital