An observational study in Acute Respiratory Distress Syndrome, sponsored by Poitiers University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Poitiers University Hospital · Observational
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.
1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
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Patients with moderate-to-severe acute respiratory distress syndrome will be included within the first 72 hours after meeting the Berlin definition criteria.
After ruling out exclusion criteria and obtaining informed consent from their relatives, patients will be included in the study.
Exclusion Criteria:
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 breath to measure the recruited volume. Then, three low-flow inflation and deflation pressure-volume curves will be performed before resuming clinical ventilator settings. Patients will be followed until Day 28 after inclusion or ICU discharge. Maneuvers performed are part of the usual care of patients with acute respiratory distress syndrome in our unit.
To assess the prevalence of "avalanche" phenomenon during low-flow lung inflation.
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.
Time frame: At inclusion
To compare characteristics of patients and their outcomes according to the existence of "avalanche" phenomenon during low-flow lung inflation.
Continuous variables will be summarized as mean ± standard deviation or median \[25th-75th percentile\] according to their distribution and compared by means of the Mann-Whitney or the Student's t test. Categorical variables will be summarized as frequency (percentage) and 95% confidence interval, and compared by means of Fisher or Chi2 test.
Time frame: Day 28
To assess the existence of an inflection point on the low-flow deflation pressure-volume curve.
The slope of the low-flow deflation pressure-volume curve will be computed by means of linear regression and summarized as mean ± standard deviation or median \[25th-75th percentile\] according to its distribution. The existence of an inflexion point will be summarized as number (percentage) and 95% confidence interval. The airway pressure corresponding to this inflexion point will be summarized as mean ± standard deviation or median \[25th-75th percentile\] according to its distribution.
Time frame: 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
The airway pressure corresponding to the inflexion point on the low-flow deflation pressure-volume curve will be summarized as mean ± standard deviation or median \[25th-75th percentile\] according to its distribution.
Time frame: At inclusion
Plan to share: Undecided
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Poitiers University Hospital