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NCT Number: NCT02662387

External Nasal Dilator and Oxygen Therapy in Respiratory Failure

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.

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Key information

Conditions

Acute Respiratory Failure

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LLUCH

Loma Linda, California, 92374, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children less than 18years
  • acute respiratory failure

Exclusion criteria

  • immediate intubation
  • >18years

Treatment and study plan

External nasal dilator (END)

Device

Applying External nasal dilator as adjuvant to high flow oxygen

Other names: nasal strip

High flow nasal cannula (HFNC)

Other

Non-invasive positive pressure ventilation

Primary outcomes

  1. 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

    Time frame: Change from baseline to time of hospital discharge, no greater than 1 month

    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)

Secondary outcomes

  1. Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU

    Time frame: From subject enrollment to hospital discharge, not >170 hr

    Actual length of stay in pediatric ICU from admission to discharge

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Acronym: HFNC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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