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High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859947
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Ege University
Information provided by (Responsible Party):
Ali Yurtseven, Ege University

Brief Summary:

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


Condition or disease Intervention/treatment
Non-invasive Ventilation Pediatric Pulmonary Disease Device: Heated humidified high-flow nasal cannula

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Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859947


Locations
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Turkey
Ege University School of Medicine, Pediatric Emergency Department
İzmir, Turkey, 35100
Sponsors and Collaborators
Ali Yurtseven
Ege University
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Responsible Party: Ali Yurtseven, Principal Investigator, Ege University
ClinicalTrials.gov Identifier: NCT03859947    
Other Study ID Numbers: 2.100.2017.0025
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Yurtseven, Ege University:
Bronchiolitis
Emergency department
High-flow nasal cannula
Flow rate
Additional relevant MeSH terms:
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Bronchiolitis
Lung Diseases
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections