High Flow Nasal Cannula Weaning in Acute Bronchiolitis

Kuopio University Hospital

Status: Enrolling

Conditions: Acute Bronchiolitis

Treatments: Other: High flow nasal cannula immediate ending; Other: High flow nasal cannula weaning

Study type: Interventional

Funder types: Other

Identifiers

NCT06321133

5402589

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Immediate ending

Experimental group

Description:

High flow is ended immediately

Treatment:

Other: High flow nasal cannula immediate ending

Weaning

Active Comparator group

Description:

High flow is ended by gradually reducing the flow rate

Treatment:

Other: High flow nasal cannula weaning