External Nasal Dilator and Oxygen Therapy in Respiratory Failure

NCT02662387 | Completed Results DMC

• 1 other identifier: 5150128
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Outcome Measures

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

  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)

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

Secondary Outcomes (1)

• Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU

  From subject enrollment to hospital discharge, not >170 hr

Study Arms (2)

High flow nasal cannula (HFNC)

ACTIVE COMPARATOR

Non-invasive positive pressure ventilation

Other: High flow nasal cannula (HFNC)

HFNC and external nasal dilator (END)

EXPERIMENTAL

high flow nasal cannula and external nasal dilator

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

Interventions

External nasal dilator (END) DEVICE

Applying External nasal dilator as adjuvant to high flow oxygen

Also known as: nasal strip

HFNC and external nasal dilator (END)

High flow nasal cannula (HFNC) OTHER

Non-invasive positive pressure ventilation

HFNC and external nasal dilator (END); High flow nasal cannula (HFNC)

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children less than 18years
• acute respiratory failure

You may not qualify if:

• immediate intubation
• \>18years

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

LLUCH

Loma Linda, California, 92374, United States

Location

Results Point of Contact

• Title: Dr. Janeth Ejike
• Organization: Loma Linda University Children's Hospital

jejike@llu.edu

9095584000

Study Officials

• Janeth Ejike, MD

  Loma Linda University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: January 25, 2016
• Study Start: February 2, 2016
• Primary Completion: May 19, 2016
• Study Completion: June 15, 2016
• Last Updated: August 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)