Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting

Study Overview
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Brief Summary
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The purpose of this study is to implement a standardized protocol to initiate nasal non-invasive ventilation with RAM nasal cannula (NIV/RAM-NC) with Trilogy mechanical ventilator at Children Memorial Hospital inpatient and outpatient sites, as well as to explore the side effects and complications associated with the use of NIV/RAM-NC in children.

Official Title
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Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Device: Nasal non-invasive ventilation with RAM cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children admitted to the Children Memorial Hermann Hospital and consulted to Pediatric Pulmonary Service for initiation of NIV/RAM-NC both at the inpatient and outpatient sites. Children who fail to wean from chronic respiratory support (CPAP, BiPAP, HFNC) in whom long-term ventilation is considered between 10/2016 - 10/2017 will be included. Exclusion Criteria: Children with minimal setting (CPAP < 5cmH2O, HFNC < 3LPM) able to be weaned to regular nasal cannula. Patients with upper airway obstruction that may be candidates for surgical procedure will be excluded.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal non-invasive ventilation with RAM cannula<br> | Device: Nasal non-invasive ventilation with RAM cannula<br>* Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Assessed by Number of Participants Who Had Complications | Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion. | 7 days after starting the RAM cannula | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal non-invasive ventilation, RAM Cannula, Pediatric Complex Care, Tracheostomy Avoidance