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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT01873261
Eligibility Criteria:
Inclusion Criteria:
* Age: \> 1 month age to 18 years
* Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
* Non intubated
* Admitted to the PICU
* Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)
Exclusion Criteria:
1. Patients younger than 1 month or older than 18 year
2. Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
3. Facial trauma/burns
4. Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
5. Fixed obstruction of the upper airway
6. Inability to protect airway
7. Life threatening hypoxemia defined as SpaO2 \<90% with FiO2 \> 0.8 on hi-flow oxygen.
8. Hemodynamic instability: refractory at volume expansion \>60 ml/kg and dopamine \>10 mcg/kg/min
9. Impaired consciousness defined as Glasgow coma scale \< 10.
10. Bowel obstruction.
11. Untreated pneumothorax.
12. Poor short term prognosis (high risk of death in the next 3 months)
13. Known esophageal problem (hiatal hernia, esophageal varicosities)
14. Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
15. Neuromuscular disease
16. Vomiting
17. Cough or gag reflex impairment.
18. Cyanotic congenital heart disease.
19. Complete absence of cooperation
20. This patient has been included (randomized) previously in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT01873261
Study Brief:
Protocol Section:
NCT01873261