External Nasal Dilator & Oxygen Therapy in Respiratory Failure

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acute Respiratory Failure
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency

Clinical Trial Details

NCT number	NCT02662387
Study type	Interventional
Source	Loma Linda University
Contact
Status	Completed
Phase	N/A
Start date	February 2, 2016
Completion date	June 15, 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

External Nasal Dilator and Oxygen Therapy in Respiratory Failure — HFNC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms