Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- transpulmonary pressure (PL)
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is characterized by acute diffuse alveolar injury caused by a variety of pulmonary and extrapulmonary factors, leading to refractory hypoxemia. It has high incidence and mortality rates. Neuromuscular blocking agents (NMBAs) play a crucial role as adjunctive therapy for ARDS, aiding in lung-protective ventilation by inhibiting excessive spontaneous breathing, improving patient-ventilator synchrony, and reducing barotrauma.
Determining the appropriate depth of muscle relaxation in moderate to severe ARDS patients receiving NMBAs remains a clinical challenge. Research has shown that partial neuromuscular blockade is feasible in certain ARDS patients. However, large randomized controlled trials (RCTs) and clinical practices often use higher doses of NMBAs to ensure complete cessation of spontaneous breathing. This indicates an ongoing debate regarding the optimal depth of neuromuscular blockade necessary for lung-protective ventilation in ARDS patients. It also raises the question of whether the optimal depth of neuromuscular blockade varies among patients with different severities of ARDS.
This study aims to investigate changes in respiratory mechanics and other physiological parameters in moderate to severe ARDS patients under different depths of neuromuscular blockade. The investigators will evaluate the impact of targeted neuromuscular blockade depth on lung protection in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe ARDS requiring the use of NMBAs, as assessed by clinicians (Berlin definition 2012: PaO2/FiO2 < 150 mmHg, PEEP ≥ 5).
- •Age: 18-85 years.
- •Signed informed consent.
排除标准
- •History of allergy to NMBAs.
- •Open chest or abdominal injuries.
- •Patients with pulmonary masses, lung transplantation, or lung resection.
- •Contraindications to esophageal catheter placement.
- •Pregnant patients.
- •Contraindications to TOF measurement (e.g., history of neuromuscular disease, presence of a cardiac pacemaker).
- •Severe dysfunction of other organs with an expected short-term mortality (within 7 days) or palliative care.
- •Previous inclusion in this study.
研究组 & 干预措施
Moderate-Severe ARDS patients
The dose of cisatracurium was gradually adjusted to achieve different depth of muscle relaxation
干预措施: cisatracurium (Drug)
结局指标
主要结局
transpulmonary pressure (PL)
时间窗: At baseline and 15 minutes after each adjustment of the cisatracurium dose.
次要结局
- train train of four count (TOF-count)(At baseline and 15 minutes after each adjustment of the cisatracurium dose.)
- esophageal pressure swing（∆Pes）(At baseline and 15 minutes after each adjustment of the cisatracurium dose.)
研究者
Lihong Xu
Resident physician
Southeast University, China