Trials / Recruiting
RecruitingNCT06321133
High Flow Nasal Cannula Weaning in Acute Bronchiolitis
High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Kuopio University Hospital · Academic / Other
- Sex
- All
- Age
- 0 Months – 12 Months
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-02-13
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2024-03-20
- Last updated
- 2025-09-03
Locations
4 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT06321133. Inclusion in this directory is not an endorsement.