NCT02662387

External Nasal Dilator and Oxygen Therapy in Respiratory Failure

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
DEVICE	External nasal dilator (END)	Applying External nasal dilator as adjuvant to high flow oxygen
OTHER	High flow nasal cannula (HFNC)	Non-invasive positive pressure ventilation

Timeline

• Start date: 2016-02-02
• Primary completion: 2016-05-19
• Completion: 2016-06-15
• First posted: 2016-01-25
• Last updated: 2017-08-21
• Results posted: 2017-07-21

Locations

1 site across 1 country: United States