External Nasal Dilator and Oxygen Therapy in Respiratory Failure

Study Overview
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Brief Summary
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Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common diagnoses in children admitted to pediatric intensive care unit. Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on HFNC and HFNC with ENDs. Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital due to acute respiratory failure secondary to bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory parameters will be collected as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.

Detailed Description
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Acute respiratory failure secondary to bronchiolitis is one of the most common diagnoses in children admitted to pediatric intensive care unit. Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on high flow nasal cannula (HFNC) and HFNC with an external nasal dilator (END). Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital between July 2015 and May 2017 for approximately 22 months due to acute respiratory failure secondary to bronchiolitis are eligible for inclusion in the study. Two arms will be studied, one with HFNC and the other with HFNC and ENDS. Modified Bronchiolitis Severity Score will be used to assess respiratory parameters as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.

Official Title
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Use of External Nasal Dilator as an Adjuvant to High-Flow Nasal Cannula Oxygen Therapy in Children With Acute Respiratory Failure: A Prospective Randomized Controlled Trial

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: External nasal dilator (END)
* Other: High flow nasal cannula (HFNC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children less than 18years acute respiratory failure Exclusion Criteria: immediate intubation >18years

Ages Eligible for Study
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Minimum Age: 1 Day
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 |
| --- | --- |
| Active Comparator: High flow nasal cannula (HFNC)<br>Non-invasive positive pressure ventilation | Other: High flow nasal cannula (HFNC)<br>* Non-invasive positive pressure ventilation<br>|
| Experimental: HFNC and external nasal dilator (END)<br>high flow nasal cannula and external nasal dilator | Device: External nasal dilator (END)<br>* Applying External nasal dilator as adjuvant to high flow oxygen<br>* Other names: nasal strip;Other: High flow nasal cannula (HFNC)<br>* Non-invasive positive pressure ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone | Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status) | Change from baseline to time of hospital discharge, no greater than 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | Actual length of stay in pediatric ICU from admission to discharge | From subject enrollment to hospital discharge, not >170 hr |