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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00817804
Eligibility Criteria:
Inclusion Criteria:
* Age \> 7 years and \< 18 years
* Weight \> 20 kg (44 lbs)
* Respiratory failure or respiratory insufficiency
* Ability to cooperate with the investigators
* Designated adult able to provide Informed Consent
Exclusion Criteria:
* An endotracheal tube or tracheostomy in place
* Hemodynamically instability
* Prolonged apnea
* Inability to maintain the airway
* A recent history of cardiac and or respiratory arrest
* Acute hemorrhage
* Multiple organ system failure
* Undrained pneumothorax
* High risk for aspiration
* Metastatic or terminal cancer
* Do-not-resuscitate orders
* Inability to clear respiratory secretions
* Inability to fit a mask
* Facial surgery, trauma, or deformity
* Upper gastrointestinal or airway surgery
* Pregnancy
* Refractory delirium
* PaO2 \< 50 mmHg on present settings
* Designee unable or unwilling to provide Informed Consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT00817804
Study Brief:
Protocol Section:
NCT00817804