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临床试验/NCT02939963
NCT02939963已完成不适用

Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
the power of work of breathing

研究概览

简要总结

Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.

Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • age 18 years or more
  • intubated and mechanically ventilated for at least 24 consecutive hours
  • staying in the medical ICU at the Croix Rousse Hospital, Lyon, France
  • pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight
  • meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine ≤ 1 mg/H, dobutamine ≤ 20 mg/h, fraction of inspired oxygen (FIO2 ≤ 50%), PEP ≤ 5 cm H2O, respiratory rate ≤ 35 breaths/min, saturation in oxygen (SpO2) ≥88%)
  • under Dräger Evita XL ou V500 ICU ventilator
  • agreement to participate from the patient or next of kin

排除标准

  • Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission
  • Tracheotomy
  • nasogastric tube contra-indicated
  • thoracic tube in place
  • no agreement to participate
  • under justice protection
  • deprived of freedom
  • pregnant or breastfeeding
  • not affiliated to social insurance
  • involved into another study that may interfere with present study

研究组 & 干预措施

ATC then pressure support 7 cm H2O PEP 4 cm H2O

Experimental

spontaneous breathing through endotracheal tube with no ventilator support except for ATC

干预措施: ATC then pressure support 7 cm H2O PEP 4 cm H2O (Procedure)

pressure support 7 cm H2O PEP 4 cm H2O then ATC

Experimental

ventilator is set to pressure support ventilation mode at set pressure 7 cm H2O above PEEP level of 4 cm H2O

干预措施: Pressure support 7 cm H2O PEP 4 cm H2O then ATC (Procedure)

结局指标

主要结局

the power of work of breathing

时间窗: 30 minutes after onset the ventilator strategy

the work of breathing is measured from the area subtended by the esophageal pressure - lung volume relationship. The power of work of breathing is obtained by multiplying work of breathing by the respiratory frequency and expressed in Joules/min

次要结局

  • occlusion pressure at 100 ms(30 minutes)
  • tidal volume(30 minutes)
  • Respiratory rate(30 minutes)
  • intrinsic PEP(30 minutes)
  • work of breathing per liter(30 minutes)
  • Distribution of pulmonary ventilation(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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