Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.

Detailed Description
-----------------
We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.

Official Title
-----------------
Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit

Conditions
-----------------
Weaning Failure

Intervention / Treatment
-----------------
* Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
* Device: Conventional oxygen therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: need for mechanical ventilation tracheal intubation surgical intensive care admission availability of extubation criteria Exclusion Criteria: prior extubation and mechanical ventilation to the actual episode weaning failure due to neurological status

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 45 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiflow Group<br>high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients. | Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)<br>* High flow and humidified oxygen support for new borns and young infants for post-extubation care<br>|
| Active Comparator: Control Group<br>Conventional oxygen therapy for post extubation care | Device: Conventional oxygen therapy<br>* conventional oxygen support for new born and young infants in post-extubation care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reintubation rate | need for mechanical ventilation support with tracheal intubation | 72 hours following prior weaning and extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-extubation respiratory failure | respiratory failure | 72 hours following prior weaning and extubation | 
| time to reintubate | time between first extubation and reintubation | 72 hours following prior weaning and extubation | 
| weaning time from oxygen. | time to wean from any oxygen supply | 72 hours following prior weaning and extubation | 
| blood pressure | blood pressure | 72 hours following prior weaning and extubation | 
| heart rate | heart rate | 72 hours following prior weaning and extubation | 
| respiratory rate | respiratory rate | 72 hours following prior weaning and extubation | 
| SpO2/FiO2 | pulsed oxygen saturation and inspired fraction of oxygen ratio | 72 hours following prior weaning and extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen therapy, post extubation care, neonatal surgical critical care, high nasal flow cannula