High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage

Study Overview
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Brief Summary
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Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.

Detailed Description
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Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Official Title
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High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: High Flow Nasal Oxygen Therapy
* Device: Nasal CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ranges from 1 to 18 years Hypercapnic respiratory failure: PaO2<60mmHg and PaCO2 >50 mmHg Candidate for non-invasive respiratory support as a result of: an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support an intention to extubate the patient being managed with intubated respiratory support to non-invasive support Exclusion Criteria: Participation in a concurrent study that prohibits the use of HHFNC Active air leak syndrome Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia PaCO2<50mmHg

Ages Eligible for Study
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Minimum Age: 1 Year
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Flow Nasal Oxygen Therapy<br>Patients are randomized to the high flow nasal oxygen therapy group | Device: High Flow Nasal Oxygen Therapy<br>* Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas<br>|
| Other: Nasal CPAP<br>Patients are randomized to the nasal continuous positive airway pressure treatment group | Device: Nasal CPAP<br>* Standard nasal CPAP via bubble or ventilator support at levels of 4-8 cm H2O<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients in each group who require endotracheal intubation w |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation-free to day 28 |  | 28 days |