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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT05056103
Eligibility Criteria:
Inclusion Criteria:
* admission to one of the participating ICUs;
* intubated with an endotracheal tube containing a cuff;
* receiving invasive mechanical ventilation; and
* expected to need invasive ventilation beyond the following calendar day at the moment of inclusion.
Exclusion Criteria:
* age \< 18 years;
* known or suspected tracheal damage, e.g., after inhalation trauma, thorax trauma, or intubation trauma;
* any condition for which deflation of the endotracheal cuff is deemed detrimental, e.g., in case high airway pressures are needed; and
* any infection, or colonization with pathogens that require strict single isolation of the patient (cohort isolation is allowed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05056103
Study Brief:
Protocol Section:
NCT05056103