Hypoxia Clinical Trial
Official title:
FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children
A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children
Breathing support is the most common intervention provided to critically ill children in a
paediatric intensive care unit (PICU). Although invasive breathing support (delivered
through a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung
damage) have prompted greater use of non-invasive respiratory support (NRS). However, there
is little scientific evidence to guide PICU clinicians on the comparative effectiveness of
the commonly used modes of NRS.
In this feasibility study, the investigators are testing whether it is possible to conduct a
randomised clinical trial comparing two modes of NRS: continuous positive airway pressure
(CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a
newer method of respiratory support. It is not known for sure how useful HFNC is in
critically ill children because there is no published research comparing it with CPAP.
However, since HFNC is easier to use and better tolerated by children, many hospitals are
now using HFNC instead of CPAP. Before HFNC is widely adopted, a clinical trial to establish
its role in the management of critically ill children is urgently needed.
As part of this study, the investigators will randomly allocate children deemed to require
NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess
whether sufficient number of children can be recruited to the trial, whether clinicians are
willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC.
The trial will run over six months, and recruit 120 sick children from three National Health
Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to
be included in the study, usually before CPAP or HFNC is started, unless emergency
life-saving treatment is required, in which case consent will be deferred until there is
more time to discuss the study with parents/guardians.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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