External Nasal Dilator and Oxygen Therapy in Respiratory Failure (HFNC)

Loma Linda University (LLU)

Status: Completed

Conditions: Acute Respiratory Failure

Treatments: Other: High flow nasal cannula (HFNC); Device: External nasal dilator (END)

Study type: Interventional

Funder types: Other

Identifiers

NCT02662387

5150128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children less than 18years
• acute respiratory failure

Exclusion criteria

• immediate intubation
• >18years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

High flow nasal cannula (HFNC)

Active Comparator group

Description:

Non-invasive positive pressure ventilation

Treatment:

Other: High flow nasal cannula (HFNC)

HFNC and external nasal dilator (END)

Experimental group

Description:

high flow nasal cannula and external nasal dilator

Treatment:

Device: External nasal dilator (END)

Other: High flow nasal cannula (HFNC)