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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03894332
Eligibility Criteria:
Inclusion Criteria:
* Glasgow Coma Scale ≥8
* presence of clearly audible cough during suctioning with need for tracheal suctioning ≤2/hour
* normal sodium blood values
* core temperature \<38.5° during the previous 8 hours
* Arterial partial pressure of oxygen to inspired oxygen fraction (PaO2/FiO2) ≥200 mmHg, with a Positive End Expiratory Pressure ≤5 cmH2O and FiO2 ≤0.4
* stable cardiovascular status (i.e., HR ≤140 beats/min, sBP between 90 and 160 mmHg without need for vasopressin, epinephrine or norepinephrine infusion, or with dopamine or dobutamine infusion ≤5 mcg/kg/min)
* cuff leak volume \>110 mL
Exclusion Criteria:
* major heart arrhythmias or cardiac ischemia
* pneumothorax or emphysema
* recent (1 week) thoracic surgery
* presence of chest burns
* pregnancy
* inclusion in other research protocols
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03894332
Study Brief:
Protocol Section:
NCT03894332