NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study

Conditions
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Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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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: Patients younger than 1 month or older than 18 year Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion Facial trauma/burns Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding Fixed obstruction of the upper airway Inability to protect airway Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen. Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min Impaired consciousness defined as Glasgow coma scale < 10. Bowel obstruction. Untreated pneumothorax. Poor short term prognosis (high risk of death in the next 3 months) Known esophageal problem (hiatal hernia, esophageal varicosities) Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube. Neuromuscular disease Vomiting Cough or gag reflex impairment. Cyanotic congenital heart disease. Complete absence of cooperation This patient has been included (randomized) previously in the study

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoiding endotracheal intubation using non-invasive ventilation | 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. | During non invasive ventilation, an average of 2-3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV |  | During mechanical ventilation after NIV | 
| Length (days) of PICU stay after NIV | The patients will be follow up after NIV during the PICU stay, and average of two weeks | After NIV | 
| Length (days) hospital stay after NIV | The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks. | After NIV | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurally Adjusted Ventilatory Assist, Pediatric Acute Respiratory Failure, non-invasive ventilation