跳至主要内容
临床试验/NCT02081105
NCT02081105终止不适用

Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
1
主要终点
Diagnostic performance of CXR to detect lung recruitability

研究概览

简要总结

Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •intubation and mechanical ventilation in the ICU
  • •Ramsay score 6 under sedation and analgesia
  • •ICU respirator implemented with pressure-volume curve device
  • •age equal to or greater than 18 years
  • •ARDS defined from the Berlin criteria
  • •absence of pneumothorax on the CXR before the study
  • •Absence of pleural effusion greater than 500 ml estimated from ultrasonography.
  • •no child-bearing woman
  • •written inform consent signed by the next of kin

排除标准

  • •Pneumothorax
  • •Pleural effusion greater than 500 ml estimated from ultrasonography
  • •Thoracic surgery in the last 3 months
  • •Contra-indication to CXR
  • •contra-indication to PEEP of 15 cm H2O
  • •contra-indication to PEEP of 15 or PEEP 15 mandated
  • •pressure-volume curve not feasible
  • •refusal to participate
  • •language barrier of the next of kin
  • •child-bearing woman
  • •person under legal protection

研究组 & 干预措施

PEEP 5

Other

level of PEEP of 5 cm H2O randomly applied to the patient

干预措施: PEEP of 5 or 15 cm H2O (Other)

PEEP 15

Other

level of PEEP of 15 cm H2O randomly applied to the patient

干预措施: PEEP of 5 or 15 cm H2O (Other)

结局指标

主要结局

Diagnostic performance of CXR to detect lung recruitability

时间窗: At day 1

1 CXR and 1 pressure-volume curve wil be performed at each PEEP for a given patient Determination of regions of interest in the posterior intercostal spaces of each lung in which density is measured to assess the total lung density at each PEEP. Measurement of Vrec between each PEEP level. One point per patient. Correlation of Vrec to change in density over all the patients and Receiver Operating Characteristic (ROC) curve of change in density to detect Vrec greater than 150 ml.

次要结局

  • static compliance(At day 1)
  • oxygenation(At day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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