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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06939920
Eligibility Criteria:
Inclusion Criteria:
* Adults admitted to the ICU prescribed NIV and stable
* Able to receive therapy on a sub-nasal (under-the-nose) mask
* Are 18 years old or older
Exclusion Criteria:
* Contraindicated for NIV
* NIV is likely to fail and/or intubation be required, at the medical staff's discretion
* Bilevel pressure of ≥ 30 cmH2O required
* Do not fit the investigational mask or the standard mask
* Pregnancy (tested under standard care)
* Unable to tolerate NIV for the duration of the investigation
* Agitated
* Unable to understand the consent process
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06939920
Study Brief:
Protocol Section:
NCT06939920