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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT01333059
Eligibility Criteria:
Inclusion Criteria:
* Less than or equal to 18 years of age
* Intubated and mechanically ventilated
* Expected to require continuous infusions of sedatives for at least 48 hours
* Parent or legal guardian available for informed consent
* Males and females of any race are eligible
Exclusion Criteria:
* Less than 72 hours after surgery
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* Critical airway (according to PICU Attending)
* Ventilator dependent (including noninvasive) on PICU admission
* Greater than 48 hours of continuous sedation infusion(s)
* Neuromuscular respiratory failure
* Managed by patient controlled analgesia (PCA) or epidural catheter
* Known allergy to any of the study medications (fentanyl or midazolam)
* Family/Medical team have decided not to provide full support (patient treatment considered futile)
* Patient requires ECMO
* Head trauma requiring intracranial pressure monitoring
* Pregnancy
* Following resuscitation from cardiorespiratory arrest whose initial pH is \< 6.9
* ICU Attending judgment that patient should be excluded for safety reasons
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01333059
Study Brief:
Protocol Section:
NCT01333059