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Clinical Trials/NCT05224323
NCT05224323
Recruiting
Not Applicable

Avalanche Phenomenon During Airways Opening in Acute Respiratory Distress Syndrome

Poitiers University Hospital1 site in 1 country50 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Poitiers University Hospital
Enrollment
50
Locations
1
Primary Endpoint
To assess the prevalence of "avalanche" phenomenon during low-flow lung inflation.
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
October 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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