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临床试验/NCT05697666
NCT05697666已完成不适用

The Depth of Neuromuscular Blockade is Not Related to Expiratory Transpulmonary Pressure and Respiratory Mechanics in Moderate to Severe ARDS Patients. A Prospective Cohort Study

Centre Hospitalier de Saint-Brieuc1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0

研究概览

简要总结

Neuromuscular blockade (NMB) is proposed in patients with moderate to severe acute respiratory distress syndrome (ARDS). The supposed benefit of these muscle relaxants could be partly linked to their effects on respiratory mechanics by reducing ventilator induced lung injuries (VILI), especially the so called atelectrauma. Although its monitoring is recommended in clinical practice, data about the depth of NMB necessary for an effective relaxation of the thoracic and diaphragmatic muscles and, therefore, the reduction of the chest wall elastance, are scarce. The investigators hypothesised that complete versus partial NMB can modify respiratory mechanics and its partitioning.

详细描述

The investigators conducted a prospective study to compare the respiratory mechanics of patients with moderate to severe ARDS according to the NMB depth, using an oesophageal pressure catheter (NutriVent®, Sidam) for transpulmonary pressure (PL) assessment, and facial train of four (TOF) for neuromuscular blockade monitoring. The oesophageal balloon was calibrated according to the method recently described to estimate the individual target volume which is assumed to be more adequate. Each patient was analysed at two different times: deep NMB (TOF = 0) and intermediate to light NMB (TOF > 0). The mechanical ventilation parameters were identical for these two measurements. The primary endpoint was the proportion of patients with expiratory transpulmonary pressure (PLexp) greater than or equal to 0 according to the NMB level, in order to assess the risk of region-dependent atelectasis and alveolar opening/closing injury (atelectrauma). Secondary endpoints included: the impact of the depth of NMB on other partition parameters of respiratory mechanics, and the variability of results according to the type of oesophageal balloon calibration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe ARDS patients with PaO2/FiO2 ratio < 150 mmHg
  • Mechanical ventilation, deep sedation and neuromuscular blockade with continuous infusion of cisatracurium for more than 24 hours
  • Presence of an oesophageal catheter
  • Written informed consent

排除标准

  • contraindication of oesophageal catheter

结局指标

主要结局

Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0

时间窗: one day

Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the level of neuromuscular blockade (%)

次要结局

  • Plateau pressure(one day)
  • Respiratory system compliance(one day)
  • Transpulmonary driving pressure(one day)
  • Pulmonary elastance(one day)
  • Driving pressure(one day)
  • Inspiratory transpulmonary pressure(one day)
  • Chest wall elastance(one day)
  • Oesophageal balloon calibration(one day)

研究者

发起方
Centre Hospitalier de Saint-Brieuc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Barbarot

Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc

Centre Hospitalier de Saint-Brieuc

研究点 (1)

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