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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT00810459
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 1years of age; \< 18 years of age
2. Greater than 5 kg
3. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O
4. Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)
Exclusion Criteria:
1. Clinically unstable, i.e.,
1. Acute Respiratory Failure
2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
3. Uncontrolled cardiac ischemia or arrhythmias
4. or as otherwise determined inappropriate for the study as determined by the investigator
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT00810459
Study Brief:
Protocol Section:
NCT00810459