Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute… (NCT04012073) | Clinical Trial Compass
TerminatedPhase 3
Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome
Stopped: The study was prematurely terminated following the funder's decision to withdraw financial support.
Italy18 participantsStarted 2022-11-01
Plain-language summary
During the acute respiratory distress syndrome (ARDS), patients' response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP on the basis of patients' individual response is warranted.
Measurement of end-expiratory lung volume (EELV) by the nitrogen washin-washout technique, bedside available from recent ICU ventilators, has been shown to reliably estimate PEEP-induced alveolar recruitment and may therefore help titrate PEEP on patient's individual requirements.
The authors designed an open-label, multicenter, randomized trial to test whether an individualized PEEP setting protocol driven by EELV may improve a composite clinical outcome in patients with moderate-to-severe ARDS.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
✓. Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
✓. Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
✓. PaO2/FiO2 ratio≤150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O.
✓. Written informed consent.
Exclusion criteria
✕. Pregnancy;
✕. Pneumothorax;
✕. Acute brain injury;
✕. Clinical signs of history of decompensated heart failure (New York Heart Association class 3-4 before the acute phase of the disease or documented ejection fraction\<35% or pulmonary capillary wedge pressure\>18 mmHg) or acute coronary syndrome;
What they're measuring
1
Composite clinical outcome that incorporates ICU mortality, 60-day ventilation-free days (VFD60) and the Area Under the Curve of the InterLeukin-6 serum concentration (IL6AUC) during the first 72 hours of observation
✕. Intubation as a result of an acute exacerbation of chronic pulmonary disease: chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc;
✕. Clinically evident intrinsic PEEP (≥2 cmH2O) during screening visit (End-expiratory pause to achieve Flow=0);