跳至主要内容
临床试验/NCT02416037
NCT02416037已完成不适用

Trans-Pulmonary Pressure and Prone Position in Ards Patients

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
4
主要终点
Value of the esophageal pressure measured at the end of expiration

研究概览

简要总结

Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.

The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • intubated
  • indication of proning
  • no contra-indication of proning

排除标准

  • contra-indication to proning
  • contra-indication to esophageal balloon
  • proning before
  • end of life decision
  • legal protection
  • pregnancy

结局指标

主要结局

Value of the esophageal pressure measured at the end of expiration

时间窗: up to 26.5 hours after inclusion

Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.

次要结局

  • End expiratory lung volume (EELV)(up to 26.5 hours after inclusion)
  • Regional lung ventilation(up to 26.5 hours after inclusion)
  • Elastance of the chest wall(up to 26.5 hours after inclusion)
  • Transpulmonary pressure at the end of expiration (Ptp,ee)(up to 26.5 hours after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验