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OpenTrials
Completed

NCT Number: NCT03859947

High-flow Nasal Cannula Flow Rates, 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

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Key information

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University School of Medicine, Pediatric Emergency Department

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heated humidified high-flow nasal cannula

Device

Non-invasive ventilation with a nasal cannula

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ali Yurtseven

Other

Collaborators

  • Ege University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2019
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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