High Flow Nasal Cannula Weaning in Acute Bronchiolitis

Not Applicable

Recruiting

• Conditions: Acute Bronchiolitis
• Interventions: Other: High flow nasal cannula immediate ending; Other: High flow nasal cannula weaning

• Registration Number: NCT06321133
• Lead Sponsor: Kuopio University Hospital

Brief 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.

Study Timeline

• Study Start: 2024-02-13
• Study First Submitted: 2024-02-13
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate ending	High flow nasal cannula immediate ending	High flow is ended immediately
Weaning	High flow nasal cannula weaning	High flow is ended by gradually reducing the flow rate

Primary Outcome Measures

Name	Time	Method
Hospitalization time from randomization	One week	Time in hours from the randomization to the time the family leaves hospital.

Secondary Outcome Measures

Name	Time	Method
Overall hospitalization time	One week	The overall time, which includes the time interval prior to randomization
Treatment failures	One week	Need to restart the high flow therapy
Readmission rate	Seven days from discharge	Need for readmission

Trial Locations

Locations (4)

Siun Sote; 🇫🇮 Joensuu, Finland

Central Finland Hospital District; 🇫🇮 Jyväskylä, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Mikkeli Central Hospital; 🇫🇮 Mikkeli, Finland