N/A
N=55
External Nasal Dilator and Oxygen Therapy in Respiratory Failure
Acute Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02662387 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: 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 — 1; 10 number/score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- External nasal dilator (END) (Device); High flow nasal cannula (HFNC) (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1; 10 | — |
| SECONDARY Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU |
73.5; 93.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- children less than 18years
- acute respiratory failure
Exclusion Criteria
- immediate intubation
- >18years
Data sourced from ClinicalTrials.gov (NCT02662387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.