Respiratory failure, not elsewhere classified
Conditions
Interventions
This is a randomized, open, non-inferiority clinical trial. Randomization will be done through sealed envelopes. Elegible patients will be divided into two groups by randomization: Group 1: High flow
Group 2: Non-Invasive Ventilation (NIV) = 126 patients. Each patient will be assessed at the time of NIV onset, 2h, 6h, 12h, 24h, 48h, 72h, and 96h after. The data to be collected during this period w
Sponsors
Hospital Municipal Infantil Menino Jesus
Hospital Municipal Infantil Menino Jesus
Eligibility
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: Children under 2 years old; hospitalized for bronchiolitis who evolved with acute respiratory distress and NIV/HFNC requirement
Exclusion criteria
Exclusion criteria: Patients with gestational age less than 35 weeks; bronchopulmonary dysplasia; cyanogenic congenital heart disease or with other alterations with hemodynamic repercussions; liver disease; neuromuscular disease; tracheostomized patients; patients with imminent indication of tracheal intubation; parents that do not agree to sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary outcome, we will assess the need for tracheal intubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be: PICU and hospital length of stay and death rate. Will also be compared: need for sedation, invasive devices used, nasal septum injury and length of mechanical ventilation (NIV and invasive). The cost involved in hospitalization (devices, medications and daily hospital stay) will also be calculated. | — |
Countries
Brazil
Contacts
Public ContactAna Carolina Santos
Hospital Municipal Infantil Menino Jesus
Outcome results
None listed