Feasibility study for a randomised trial of first-line respiratory support
Research type
Research Study
Full title
FIRST-line support for Assistance in Breathing in Children (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
IRAS ID
185074
Contact name
NA NA
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
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 life saving, 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, we 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. We do not know 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, we will randomly allocate children deemed to require NRS by their treating clinician to either HFNC or CPAP. We 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 6 months, and recruit 120 sick children from three NHS hospitals. We will seek consent from parents/carers 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 we will defer consent until there is more time to discuss the study with parents/carers.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0296
Date of REC Opinion
27 Aug 2015
REC opinion
Favourable Opinion