Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07423520
Eligibility Criteria:
Inclusion Criteria:
* acute respiratory failure with onset \< 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;
* bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses;
* pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis;
* PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;
Exclusion Criteria:
* age \<18 years;
* pregnancy;
* signs of barotrauma or documented pneumothorax;
* severe tachycardia (HR \> 120 bpm) and severe lacticaemia (lac \> 4 mmol/L)
* pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction \< 35%);
* contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);
* intubation as a result of an acute exacerbation of chronic pulmonary disease;
* contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07423520
Study Brief:
Protocol Section:
NCT07423520