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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04541602
Eligibility Criteria:
Inclusion Criteria:
* adult patients above 17 years of age
* Sequential organ failure assessment (SOFA) score ≥8 within the first two days after ICU admission
* invasive mechanical ventilation ≥48 hours
Exclusion Criteria:
* no written informed consent from patient or legal representative
* participation in another interventional study
* patient transfer from another hospital (\>1 day hospital stay)
* preexisting swallowing disorder or disease of the larynx, pharynx or esophagus
* previous surgery of the larynx, pharynx, esophagus or maxillofacial surgery
* preexisting neuromuscular diseases
* preexisting central nervous system diseases (stroke, hemorrhage, tumor, traumatic brain injury, brain surgery, epilepsy, hydrocephalus)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04541602
Study Brief:
Protocol Section:
NCT04541602