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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT04741256
Eligibility Criteria:
Inclusion Criteria:
Patient participants:
* Diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy
* No previous record of tracheostomy
* Has an identified family caregiver who is willing to participate
* Has the tracheostomy in place for at least 10 days after discharge
Caregiver participants:
* Family member or friend, who is 18 years or older, of an adult patient described above
* Identified by the patient as his/her primary caregiver who is providing daily assistance
Exclusion Criteria:
* Patients who do not have a caregiver
* Caregivers who are illiterate.
* Caregivers with previous tracheostomy experience.
* Patients who are decannulated from tracheostomy prior to discharge.
* Patients discharged to a skilled nursing facility at the time of discharge.
* Patients who are tolerating continuous tracheostomy capping at time of discharge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04741256
Study Brief:
Protocol Section:
NCT04741256