External Nasal Dilator and Oxygen Therapy in Respiratory Failure
NCT ID: NCT02662387
Last Updated: 2017-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
55 participants
INTERVENTIONAL
2016-02-02
2016-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High Flow Nasal Cannula Rates in Pediatric Asthma
NCT06379607
High Flow in Infants With Bronchiolitis
NCT02913040
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
NCT02587832
Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures
NCT06947902
Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis
NCT01498094
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HFNC and external nasal dilator (END)
high flow nasal cannula and external nasal dilator
External nasal dilator (END)
Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC)
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC)
Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC)
Non-invasive positive pressure ventilation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
External nasal dilator (END)
Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC)
Non-invasive positive pressure ventilation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* acute respiratory failure
Exclusion Criteria
* \>18years
1 Day
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Loma Linda University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Janeth Chiaka Ejike, MD
Associate Professor, Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janeth Ejike, MD
Role: STUDY_DIRECTOR
Loma Linda University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LLUCH
Loma Linda, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5150128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.