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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT05644418
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older;
* Informed consent form signed by the subject or a legal representative;
* Controlled mechanical ventilation via an endotracheal tube -
* FiO2 ≤50% and PEEP 10 cmH2O or lower
Exclusion Criteria:
* Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
* Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of \<100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS
* Untreated pneumothorax (i.e. no pleural drainage)
* Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose \>0.4mg/kg/min
* Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)
* Thoracic wounds, bandages or other obstruction which prevent proper functioning of the EIT device
* High (\>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
* An inner tube diameter of 6mm or less
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05644418
Study Brief:
Protocol Section:
NCT05644418