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NCT03859947 Clinical Trial

High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis

Non-invasive Ventilation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03859947
Other study ID # 2.100.2017.0025
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2017
Est. completion date October 31, 2018

Study information
Verified date February 2019
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Heated humidi?ed high-flow nasal cannula
Non-invasive ventilation with a nasal cannula

Locations
Country Name City State
Turkey Ege University School of Medicine, Pediatric Emergency Department Izmir

Sponsors (2)
Lead Sponsor Collaborator
Ali Yurtseven Ege University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment failure rate 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
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