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临床试验/NCT05224323
NCT05224323招募中不适用

Avalanche Phenomenon During Airways Opening in Acute Respiratory Distress Syndrome

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
To assess the prevalence of "avalanche" phenomenon during low-flow lung inflation.

研究概览

简要总结

Acute respiratory distress syndrome accounts for 23% of mechanically ventilated patients and is associated with high mortality rate. Although life-saving, mechanical ventilation may worsen lung injury through two main mechanisms: lung overdistension and atelectrauma. Indeed, the cyclic opening and closure of airways during tidal ventilation may cause lung and bronchial injuries as suggested by animal models and autopsy findings. Complete airways closure has recently been described in 40% of patients with acute respiratory distress syndrome, and setting positive end-expiratory pressure above the airway opening pressure may limit atelectrauma. However, animal and mathematical models suggest that above the airway opening pressure, more distal airways open unevenly according to their own opening pressure, resulting in an "avalanche"-like phenomenon during lung inflation. This phenomenon has never been described in humans. A better understanding of the opening of airways in acute respiratory distress syndrome may help to limit ventilation-induced lung injury and to improve outcomes.

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 acute respiratory distress syndrome within the first 72 hours after meeting the Berlin definition criteria:
  • Within 1 week of a known clinical insult or new or worsening respiratory symptoms;
  • Bilateral opacities (not fully explained by effusions, lobar/lung collapse, or nodules);
  • Respiratory failure not fully explained by cardiac failure or fluid overload;
  • PaO2/FiO2 ≤ 200 mmHg with positive end-expiratory pressure ≥ 5 cmH2O.
  • Absence of spontaneous breathing efforts
  • Consent to participate to the study from the patient and/or its surrogate

排除标准

  • Pneumothorax
  • Broncho-pleural fistula
  • Tracheostomy
  • Hemodynamic instability
  • Severe hypoxemia
  • Suspected of proven intracranial hypertension
  • Chronic obstructive lung disease
  • Pacemaker or defibrillator
  • Decision to withhold of withdraw life-sustaining measures
  • Under protection

结局指标

主要结局

To assess the prevalence of "avalanche" phenomenon during low-flow lung inflation.

时间窗: At inclusion

The distribution of pressure drops on low-flow inflation pressure-volume curves will be described and plotted on a log-log scale graph. "Avalanche" phenomenon will be defined if this distribution follows power law (i.e. is linear on a log-log scale) with a R2 ≥ 0.80. The prevalence of "avalanche" phenomenon will be described as frequency and 95% confidence interval.

次要结局

  • To compare characteristics of patients and their outcomes according to the existence of "avalanche" phenomenon during low-flow lung inflation.(Day 28)
  • To assess the existence of an inflection point on the low-flow deflation pressure-volume curve.(At inclusion)
  • To assess the airway pressure value of the inflection point on the low-flow deflation pressure-volume curve in patients with an inflexion point on the low-flow deflation pressure-volume curve(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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