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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT07033702
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Chronically (\>1 month) tracheostomy-dependent outpatients
* Currently not requiring ventilatory or supplemental oxygen support
* Have undergone at least one prior tracheostomy tube exchange
* Scheduled for routine in-office tracheostomy tube exchange
* Able to provide informed consent
Exclusion Criteria:
* Active respiratory infection
* Patients with airway tubes having an inner diameter less than 6.0 mm
* Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS)
* Patients who are tracheostomy-dependent but cannot be orotracheally intubated.
* Patients unable to provide informed consent and who have no legally authorized representative.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07033702
Study Brief:
Protocol Section:
NCT07033702