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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT02762292
Eligibility Criteria:
Inclusion Criteria:
All intubated and mechanically ventilated children \>1 months and \<18 years old, hospitalized in the pediatric intensive care unit will be eligible.
The patient is deemed to be ready for an extubation readiness test as per the attending team. In particular, the following criteria should be met:
* Improvement in the underlying condition that led to intubation;
* Presence of spontaneous breathing, and adequate oxygenation:, FiO2 ≤ 0.6 (to obtain a SpO2 between 92 and 97%), with Positive End Expiratory Pressure \< 8 cmH2O;
* Adequate mental status: Arousal;
* Effective cough;
* No planned operative procedure requiring heavy sedation in the next 12 hours.
Exclusion Criteria:
* Contraindications to the placement of a new nasogastric tube (e.g. trauma or recent surgery in cervical, esophageal, or nasopharyngeal regions, severe coagulation disorder);
* Hemodynamic instability requiring milrinone ≥ 0.5µg/kg/min, dopamine ≥ 5µg/kg/min, epinephrine ≥ 0.03µg/kg/min, norepinephrine ≥ 0.03µg/kg/min, or dobutamine ≥ 5µg/kg/min;
* Severe respiratory instability, and in particular PaCO2 \> 80 mmHg on the last blood gas in the last 4 hours;
* Axillary temperature \>38°;
* Cuff leaks \>10%, calculated by the ventilator as mean inspired tidal volume minus mean expired tidal volume divided by inspired tidal volume;
* Absence of parental or tutor consent;
* Patient for whom a limitation of life support treatments is discussed or decided.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT02762292
Study Brief:
Protocol Section:
NCT02762292