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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT01086995
Eligibility Criteria:
Inclusion Criteria:
* Patients who have been requiring mechanical ventilation for \>48 hours.
* At least partial reversal of the condition precipitating invasive ventilation.
* Stabilization of "other" organ system failures (i.e. no worsening).
* The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O)
* The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors).
* Stable neurological status (no deterioration in the last 24 hors, intact respiratory drive and ICP \< 20).
* The patient has intact airway reflexes (adequate cough with suctioning and a gag reflex).
Exclusion Criteria:
* Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis).
* Do not reintubate order documented on chart or anticipated withdrawal of life support.
* Tracheostomy
* Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia.
* Severe heart failure or Grade IV left ventricular function.
* Prior extubation during ICU stay.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01086995
Study Brief:
Protocol Section:
NCT01086995