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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT03041402
Eligibility Criteria:
The investigators considered eligible:
* any patient ≥18 years admitted in ICU undergoing invasive mechanical ventilation for at least 48 hours with a Glasgow Coma Scale (GCS) of 11 (i.e.; spontaneous eyes opening, obeys to command, no verbal response because of the endotracheal tube in place),
* no infusion of midazolam and propofol in the previous 24 and 4 hours, respectively
* ready for extubation with indication, prior to extubation, to receive prophylactic NIV to prevent post-extubation respiratory failure.
Patients were excluded in case of
* need for analgesic or sedative drugs,
* recent cervical spine injury,
* obstructive sleep apnoea syndrome,
* pregnancy,
* contraindications to placement of a nasal-gastric feeding tube,
* inclusion in other research protocol
* lack of consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03041402
Study Brief:
Protocol Section:
NCT03041402