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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT02286869
Eligibility Criteria:
Inclusion Criteria:
patients consecutively admitted to the mixed intensive care unit of the Luigi Sacco Hospital with (all the following):
* mechanical ventilation with an expected duration ≥ 48 hours
* acute respiratory failure due to ALI/ARDS or COPD exacerbation or pneumonia or severe sepsis/septic shock
* age between 18 and 75 years old
Exclusion Criteria:
* contraindications to esophageal tube positioning (i.e. esophageal varices, bleeding from upper enteric tract in the past 30 days)
* history of esophageal or gastric or thoracic surgery
* history of neuromuscular disease or stroke or head trauma
* history of thyroidal or adrenal dysfunction
* positive end expiratory pressure ≥ 10 cmH2O and/or inspiratory oxygen fraction ≥ 0.60, or intrinsic positive end expiratory pressure ≥ 8 cmH2O
* needing for neuromuscular blocking drugs administration
* patients unable to undergo to patient-driven mechanical ventilation mode (i.e. coma, excessive sedation)
* mechanical circulatory support (i.e. intra-aortic balloon, extracorporeal membrane oxygenation)
* norepinephrine ≥0.3 mcg/kg/min or epinephrine ≥0.05 mcg/kg/min or dobutamine ≥2.5 mcg/kg/min
* non sinus cardiac rhythm or ectopic beats exceeding ≥5% of normal sinus beats
* acute or chronic heart failure with reduced or preserved ejection fraction
* recent acute miocardial infarct ≤6 months
* recent recovery from respiratory failure or pneumonia or severe sepsis/septic shock ≤30 days
* therapy with beta-blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02286869
Study Brief:
Protocol Section:
NCT02286869