High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis

February 27, 2019 updated by: Ali Yurtseven

Comparison of Heated humidified High-flow Nasal Cannula Flow Rates (1-L/kg/Min vs 2-L/kg/Min) in the Management of Severe Bronchiolitis

Objective: The investigators aimed to compare the heated humidified high-flow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department.

Study design: The investigators performed a study in which all patients were allocated to receive these two flow rates. The primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. Secondary outcomes covered a decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS), rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and intensive care unit (ICU) admission.

Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Ege University School of Medicine, Pediatric Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with a clinical diagnosis of severe bronchiolitis, aged less than 24 months and presenting to the emergency department

Description

Inclusion Criteria:

  • Clinical diagnosis of severe bronchiolitis
  • Must be less than 24 months
  • Must have presented to the emergency department

Exclusion Criteria:

  • Immediate invasive ventilation and/or intensive care unit admission
  • Congenital heart disease,
  • Chronic lung disease
  • Neuromuscular disease
  • Netabolic disease
  • Craniofacial anomalies
  • Immunocompromised
  • Bacterial pneumonia
  • Pneumothorax
  • Nasal trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute bronchiolitis
Device: Heated humidified high-flow nasal cannula
Non-invasive ventilation with a nasal cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure rate
Time Frame: Within 24 hours
We compared the treatment failure between the 1-L/kg/min flow rate with 2-L/kg/min rate in patients with severe bronchiolitis
Within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Yurtseven

Collaborators

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.100.2017.0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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