Acute Respiratory Failure
Conditions
Keywords
Neurally Adjusted Ventilatory Assist, Pediatric Acute Respiratory Failure, non-invasive ventilation
Brief summary
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Detailed description
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm. Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients. Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly. There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
Interventions
None listed
Sponsors
Hospital Universitario La Paz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Avoiding endotracheal intubation using non-invasive ventilation | During non invasive ventilation, an average of 2-3 days. | The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV). It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV | During mechanical ventilation after NIV | — |
| Length (days) of PICU stay after NIV | After NIV | The patients will be follow up after NIV during the PICU stay, and average of two weeks |
| Length (days) hospital stay after NIV | After NIV | The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks. |
Countries
Spain
Contacts
Primary ContactPedro De la Oliva, MD, PhD
Outcome results
None listed