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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02988167
Eligibility Criteria:
Inclusion Criteria:
1. patients who have been or are expected to be on mechanical ventilation for \> 48 hours in total prior to extubation,
2. patients who are ready for Spontaneous Breathing Test (SBT) for assessment for extubation,
3. the patients who are able to tolerate pressure support ventilation ≤ 14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP 10 ≤ cm H20,
4. patients who are hemodynamically stable (off vasopressors or on low levels of vasopressors: phenylephrine \< 50 ug/min; norepinephrine \< 5 ug/min; dobutamine \< 5 ug/kg/min; milrinone\< 0.4 ug/kg/min),
5. patients whose neurological status is stable (no deterioration in the last 24 hrs, intact respiratory drive and ICP \<20),
6. patients who have intact airway reflexes (adequate cough with suctioning and a gag reflex), and
7. patient who are in normal sinus rhythm at the time of the SBT (no pacemaker).
Exclusion Criteria:
1. patients who have "do not re-intubate" order documented on their chart or if withdrawal of life support is anticipated,
2. patients who have a tracheostomy,
3. patients who suffer from known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia,
4. patients who have been previously extubated during the same ICU admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02988167
Study Brief:
Protocol Section:
NCT02988167