High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis

NCT ID: NCT03859947

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Non-invasive Ventilation Pediatric Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute bronchiolitis

Heated humidified high-flow nasal cannula

Intervention Type DEVICE

Non-invasive ventilation with a nasal cannula

Interventions

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Heated humidified high-flow nasal cannula

Non-invasive ventilation with a nasal cannula

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role collaborator

Ali Yurtseven

OTHER

Sponsor Role lead

Responsible Party

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Ali Yurtseven

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ege University School of Medicine, Pediatric Emergency Department

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2.100.2017.0025

Identifier Type: -

Identifier Source: org_study_id

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