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Идёт набор NCT05224323

Avalanche Phenomenon During Airways Opening in Acute Respiratory Distress Syndrome

— Наблюдательное Acute Respiratory Distress Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Airway pressure, flow, esophageal pressure, ventilation distribution.
Кому может быть актуально
Состояния в реестре: Acute Respiratory Distress Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Другое Airway pressure, flow, esophageal pressure, ventilation distribution
    After informed consent, baseline characteristics of patients will be collected. Airway pressure, flow and esophageal pressure will be recorded using high sampling rate and ventilation distribution using electrical impedance tomography will be recorded during the study. The ventilator will be set at a positive end-expiratory pressure of 15 cmH2O during 10 minutes. Then, respiratory rate will be decreased to 8 breaths/min, and positive end-expiratory pressure will be decreased to 5 cmH2O over one

Первичные конечные точки

  • To assess the prevalence of "avalanche" phenomenon during low-flow lung inflation. [Срок оценки: At inclusion]
Вторичные конечные точки (3)
  • To compare characteristics of patients and their outcomes according to the existence of "avalanche" phenomenon during low-flow lung inflation. [Срок оценки: Day 28]
  • To assess the existence of an inflection point on the low-flow deflation pressure-volume curve. [Срок оценки: 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 [Срок оценки: At inclusion]

Критерии участия

Критерии включения

  • Age ≥ 18
  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU Poitiers — Poitiers

Публикации

  • Suki B, Barabasi AL, Hantos Z, Petak F, Stanley HE. Avalanches and power-law behaviour in lung inflation. Nature. 1994 Apr 14;368(6472):615-8. doi: 10.1038/368615a0. PMID 8145846
  • Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10.1164/rccm.201702-0388LE. No abstract available. PMID 28557528

Идентификаторы

NCT: NCT05224323 · AVALANCHE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗