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临床试验/NCT02342756
NCT02342756Unknown不适用

Esophageal Pressure-Guided Optimal PEEP/mPaw in CMV and HFOV: The EPOCH Study

University of Toronto4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
4
主要终点
Ventilator-induced lung injury (VILI) in patients with ARDS as measured by serum cytokines

研究概览

简要总结

The use of positive end-expiratory pressure (PEEP) has been shown to prevent the cycling end-expiratory collapse during mechanical ventilation and to maintain alveolar recruitment, keeping lung portions open, increasing the resting end-expiratory volume. On the other hand PEEP may also overdistend the already open lung, increasing stress and strain.

Theoretically high frequency oscillatory ventilation (HFOV) could be considered an ideal strategy in patients with ARDS for the small tidal volumes, but the expected benefits have not been shown yet.

PEEP and HFOV should be tailored on individual physiology. Assuming that the esophageal pressure is a good estimation of pleural pressure, transpulmonary pressure can be estimated by the difference between airway pressure and esophageal pressure (PL= Paw - Pes). A PL of 0 cmH2O at end-expiration should keep the airways open (even if distal zones are not certainly recruited) and a PL of 15 cmH2O should produce an overall increase of lung recruitment.

The investigators want to determine whether the prevention of atelectrauma by setting PEEP and mPaw to obtain 0 cmH2O of transpulmonary pressure at end expiratory volume is less injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a threshold of 15 cmH2O of transpulmonary pressure.

The comparison between conventional ventilation with tidal volume of 6 ml/Kg and HFOV enables us to understand the role of different tidal volumes on preventing atelectrauma and inducing lung recruitment.

The use of non-invasive bedside techniques such as lung ultrasound, electrical impedance tomography, and transthoracic echocardiography are becoming necessary in ICU and may allow us to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV.

详细描述

The absolute value of esophageal pressure (Pes), measured during an end-expiratory pause can be considered a good surrogate for pleural pressure (Ppl), and the difference between airway pressure (Paw) and Pes a valid estimation of transpulmonary pressure (PL). Although this method has not been tested in large clinical trials yet, the utility of Pes in guiding therapy of ARDS has been shown in EPVent study.

Therefore, assuming that Pes is a good estimation of Ppl, PEEP and mPaw could be targeted to obtain different value of PL. A PL of 0 cmH2O at end-expiratory pause, should keep the airways open (even if distal zones are not certainly recruited) and a PL of 15 cmH2O at end-inspiratory pause should produce an overall increase of lung recruitment, limiting tidal overdistension. The comparison of these two different ventilatory settings allows us to determine whether the prevention of atelectrauma by setting PEEP and Paw of HFOV to obtain 0 cmH2O of transpulmonary pressure at end-expiratory occlusion is less injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a threshold of 15 cmH2O of transpulmonary pressure.

The use of HFOV beside conventional ventilation, enables us to understand the role of these ventilatory strategies with different end-expiratory volumes, on preventing atelectrauma and inducing lung recruitment.

In addition the use of non-invasive bedside techniques as pleural and lung ultrasonography (PLUS), electrical impedance tomography (EIT), and transthoracic echocardiography (TTE) may allow us to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV, and may help in the assessment of recruitable lungs.

Primary objective:

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate or severe ARDS, defined according to the Berlin definition (2);
  • Endotracheal intubation or tracheostomy

排除标准

  • Severe heart failure/cardiogenic shock;
  • Pulmonary arterial hypertension requiring systemic vasodilators;
  • Contraindications to esophageal balloon: esophageal pathology (stricture, perforation, high grade of varices), recent history of esophageal or gastric surgery, upper GI tract bleeding, severe coagulopathy and nasal trauma;
  • Contraindications to Electrical Impedance Tomography (EIT): a temporary or permanent pacemaker, or implantable cardioverter-defibrillator (ICD);
  • Age < 16 years.

研究组 & 干预措施

Group 1: CMV - HFOV

Experimental

Patients in group 1 will start with conventional mechanical ventilation with different values of PEEP (A-PEEP so that PLEEO = 0 cmH2O, B- PEEP so that PLEIO = 15 cmH2O, C- PEEP so that PLEEO = 0 cmH2O) and then will be ventilated with high frequency oscillatory ventilation (D- mPaw so that PL = 0 cmH2O, E- mPaw so that PL = 15 cmH2O, F- mPaw so that PL = 0 cmH2O)

Intervention: Device: Targeting transpulmonary pressure to avoid VILI

干预措施: Targeting transpulmonary pressure to avoid VILI (Device)

Group 2: HFOV - CMV

Experimental

Patients in group 2 will start with high frequency oscillatory ventilation (D- mPaw so that PL = 0 cmH2O, E- mPaw so that PL = 15 cmH2O, F- mPaw so that PL = 0 cmH2O) and then will be ventilated with conventional mechanical ventilation with different values of PEEP (A-PEEP so that PLEEO = 0 cmH2O, B- PEEP so that PLEIO = 15 cmH2O, C- PEEP so that PLEEO = 0 cmH2O).

Intervention: Device: Targeting transpulmonary pressure to avoid VILI

干预措施: Targeting transpulmonary pressure to avoid VILI (Device)

结局指标

主要结局

Ventilator-induced lung injury (VILI) in patients with ARDS as measured by serum cytokines

时间窗: 1 hour after initiation of each experimental ventilation strategy

IL-6, TNF, IL-10, IL-1β, and IL-1ra and other cytokines will be detected in EDTA plasma with commercially available enzyme-linked immunosorbent assays (ELISA)

次要结局

  • Impact of transpulmonary pressure on right ventricular function (RV)(1 hour after initiation of each experimental ventilation strategy)
  • Assessment of lung recruitment and tidal overdistension(1 hour after initiation of each experimental ventilation strategy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eddy Fan

Eddy Fan, MD, PhD, Assistant Professor of Medicine, Interdepartmental Division of Critical Care Medicine

University of Toronto

研究点 (4)

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