High Flow Nasal Cannula Weaning in Acute Bronchiolitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High flow nasal cannula immediate ending, High flow nasal cannula weaning.
- Who it may be relevant to
- Registry conditions: Acute Bronchiolitis. Basic parameters: 0 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
Overview
The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.
Detailed description
Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients.
Interventions
- Other High flow nasal cannula immediate ending
High flow is immediately ended - Other High flow nasal cannula weaning
High flow is gradually weaned by reducing the flow rate
Primary outcome measures
- Hospitalization time from randomization [Time frame: One week]
Secondary outcome measures (3)
- Treatment failures [Time frame: One week]
- Readmission rate [Time frame: Seven days from discharge]
- Overall hospitalization time [Time frame: One week]
Eligibility criteria
Inclusion criteria
- Clinically diagnosed acute bronchiolitis
- High flow nasal cannula treatment has lasted for at least 12 hours
- Measured saturation 95 or more with room air
- High flow rate is maximum 2l/kg/min
- The treating doctors considers the infant suitable to be without high flow
Exclusion criteria
- Major congenital anomaly of lungs, hearts or diaphragm
- Bacterial pneumonia
- Parents do not give consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 4 centers
- Siun Sote — Joensuu
- Central Finland Hospital District — Jyväskylä
- Kuopio University Hospital — Kuopio
- Mikkeli Central Hospital — Mikkeli
Identifiers
NCT: NCT06321133 · 5402589