Bronchiolitis
Conditions
Keywords
infant, high flow nasal cannulae, oxygen therapy, bronchiolitis
Brief summary
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Detailed description
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis. The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation \<92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
Interventions
DEVICEAirvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device
DEVICEMedKit Finland - Usual oxygen therapy
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Admission to pediatric ward due to a presumed viral bronchiolitis * Need of oxygen therapy (oxygen saturation \< 92%)
Exclusion criteria
* Pertussis * Needs intubation or CPAP on admission * Severe congenital heart defect * Down's syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment failure | 720 hours | Treatment failure = need for change of respiratory support method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate measured by the study physician/nurse | At 30 min, 60 min, 90 min, 4 hours, 8 hours | — |
| Oxygen saturation (%) | At 30 min, 60 min, 90 min, 4 hours, 8 hours | — |
| Time from randomisation to end of oxygen therapy | At 30 min, 60 min, 90 min, 4 hours, 8 hours | — |
| Time from hospital admission to discharge (hours) | 720 hours | The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups. |
| Number of participants needing admission to intensive care unit (ICU) | 720 hours | The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups. |
Countries
Finland
Outcome results
None listed