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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External nasal dilator (END)
High flow nasal cannula (HFNC)
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children less than 18years
  • acute respiratory failure

Exclusion Criteria:

  • immediate intubation
  • >18years

Sites / Locations

  • LLUCH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High flow nasal cannula (HFNC)

HFNC and external nasal dilator (END)

Arm Description

Non-invasive positive pressure ventilation

high flow nasal cannula and external nasal dilator

Outcomes

Primary Outcome Measures

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
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 Outcome Measures

Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU
Actual length of stay in pediatric ICU from admission to discharge

Full Information

First Posted
September 1, 2015
Last Updated
July 21, 2017
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02662387
Brief Title
External Nasal Dilator and Oxygen Therapy in Respiratory Failure
Acronym
HFNC
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
May 19, 2016 (Actual)
Study Completion Date
June 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow nasal cannula (HFNC)
Arm Type
Active Comparator
Arm Description
Non-invasive positive pressure ventilation
Arm Title
HFNC and external nasal dilator (END)
Arm Type
Experimental
Arm Description
high flow nasal cannula and external nasal dilator
Intervention Type
Device
Intervention Name(s)
External nasal dilator (END)
Other Intervention Name(s)
nasal strip
Intervention Description
Applying External nasal dilator as adjuvant to high flow oxygen
Intervention Type
Other
Intervention Name(s)
High flow nasal cannula (HFNC)
Intervention Description
Non-invasive positive pressure ventilation
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
Change from baseline to time of hospital discharge, no greater than 1 month
Secondary Outcome Measure Information:
Title
Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU
Description
Actual length of stay in pediatric ICU from admission to discharge
Time Frame
From subject enrollment to hospital discharge, not >170 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children less than 18years acute respiratory failure Exclusion Criteria: immediate intubation >18years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janeth Ejike, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
LLUCH
City
Loma Linda
State/Province
California
ZIP/Postal Code
92374
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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External Nasal Dilator and Oxygen Therapy in Respiratory Failure

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