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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT00977002
Eligibility Criteria:
Inclusion Criteria:
Patients aged between 28 days and 15 years and who were intubated and remained under invasive mechanical ventilation for 48 hours, passed in the extubation test for, and who presented at least one of the following risk factors for respiratory distress post extubation:
1. Invasive ventilation for at least 15 days
2. Use of inotropics for more than 48 hours
3. Endovenous continuous administration of sedative/analgesic drugs
4. 1-3 months old
5. Mean Airway Pressure(Paw)\> 8,5; Inspired fraction of O2(FiO2)\> 0,4; Oxygenation index(IO)\> 4,5 immediately before extubation
6. Cardiac or pulmonary chronic diseases
7. Cardiac output
8. Hipercapny: Arterial pressure of CO2 (PaCO2)\> 45 mmHg
Exclusion Criteria:
1. Tracheostomized
2. Accidental extubation
3. Respiratory failure just after extubation, needing immediate reintubation
4. Neuromuscular diseases
5. Death
6. PPNIV exclusion: coma or disability to protect airway, not tolerated, hemodynamic instability, shock, cardiac disritmy, facial or intracranial traumatic injury or surgery that preclude use of mask, abdominal distension, nausea or vomiting, gastric or esophagic recent surgery, gastrointestinal hemorrhagy in activity, not drained pneumothorax.
7. Reintubated patients during its stay in PICU, that have already participated in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
15 Years
Study:
NCT00977002
Study Brief:
Protocol Section:
NCT00977002