To evaluate the effect on severity of dyspnoea of administration of oxygen through High Flow Nasal Cannula compared to oxygen delivery through Low Flow Nasal Prongs in children hospitalized for bronchiolitis with moderate to severe dyspnoea.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in dyspnoea severity, depicted by decrease in PEWS with >= 2 points
within 24 hours. PEWS will be assessed at t=0, 1, 2 and 3 hours and thereafter
at least every three hours during hospitalisation, or more frequent, as
indicated.
Secondary outcome
Respiratory rate, retractions, heart rate, conscious state, oxygen saturation,
FiO2, temperature, Comfort (FLACC), ability to feed, tube feeding, intravenous
fluids, bloodgas analysis (in case of PEWS >= 8, or as indicated by the treating
physician), mechanical ventilation, referral to PICU, length of hospitalization.
By measuring these different variables we are able to compose several composite
dyspnoea scores other than the PEWS (i.e. RDAI Respiratory Distress Assessment
Instrument, PRAM Pediatric Respiratory Assessment Measurement). None of these
scores is sufficiently validated, however by measuring the most frequently
used, we will enable comparison of our data with other studies.
Background summary
Bronchiolitis is a common respiratory tract illness in young children, usually
of viral origin, causing a clinical picture of dyspnoea due to airway
obstruction and feeding problems.[Florin 2016] During winter seasons,
bronchiolitis is an important reason for hospital admissions in young children.
Since no pharmacological intervention has been proven effective, treatment is
supportive, existing of oxygen supplementation and/or administration of
fluids.[Ralston 2014] Traditionally, oxygen is given as dry gas through
low-flow nasal prongs (LFNP). In the recent years a new method of oxygen
supplementation has been used, delivering oxygen through heated humidified,
high flow nasal cannula (HFNC). From retrospective studies and descriptive case
series it is hypothesized that HFNC leads to better relieve of dyspnoea
symptoms, less need for invasive respiratory support and less discomfort.
[Hutchings 2015] However no solid evidence for the effect of HFNC has been
shown from randomized controlled trials.[Cochrane 2014, Haq 2014]
Bronchiolitis is an illness for which there are very limited proven treatment
options. To establish HFNC as an effective and safe intervention in
bronchiolitis has significant clinical implications. This intervention may
provide an effective form of respiratory support that is less invasive and
potentially has lower costs and fewer adverse events than conventional
non-invasive ventilation therapy.
Several authors, including Cochrane reviewers emphasize the importance and
urgent need for randomized controlled trials on this subject. [Cochrane 2014,
Korppi 2016]
Study objective
To evaluate the effect on severity of dyspnoea of administration of oxygen
through High Flow Nasal Cannula compared to oxygen delivery through Low Flow
Nasal Prongs in children hospitalized for bronchiolitis with moderate to severe
dyspnoea.
Study design
Multi Centre, Randomized controlled trial comparing oxygen supplementation via
High Flow Nasal Cannula with oxygen supplementation via Low Flow Nasal Prongs.
Intervention
Standard mode of oxygen delivery (in the control group) is through dry gas at a
limited flow rate < 2 L/min using nasal prongs. Higher flow rates of dry gas
through nasal prongs are experienced as painful and uncomfortable air streams.
The intervention in our study is the use of High Flow Nasal Canula to deliver
oxygen to included patients. Through heating (to body temperature) and
humidification (>99% relative humidity) of oxygen and air mixtures, comfortable
oxygen delivery is allowed at flow rates matching or exceeding the patient*s
inspiratory flow rate, thus limiting entrainment of room air.
Study burden and risks
Both intervention require the placement of nasal canula*s or prongs, which may
cause some inconvenience or discomfort to the child. Potential risks of High
Flow may be abdominal distension, infections from the heated humidifying system
or pneumothorax. However these risks are estimated to be very low and the use
of High Flow has been supposed to be safe till so far. Patients are not exposed
to any burden related to the collection of data; no extra blood samples or
invasive measurements are performed. Since bronchiolitis is an age specific
disease, occurring only - by definition - in children < 2 years of age, this
study cannot be done in elder pediatric patients, nor in adults.
Dr van Heesweg 2
Zwolle 8000 GK
NL
Dr van Heesweg 2
Zwolle 8000 GK
NL
Listed location countries
Age
Inclusion criteria
Patients < 2 years of age, hospitalised for bronchiolitis, with need for oxygensupplementation and moderate to severe dyspnoea.
Exclusion criteria
Bronchopulmonary dysplasia
Congenital heart disease
Congenital pulmonary abnormalities
Syndromal disease (for example trisomie 21)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinical trial.gov, nummer volgt |
| CCMO | NL56959.075.16 |