FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study
NCT ID: NCT02612415
Last Updated: 2016-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
121 participants
INTERVENTIONAL
2015-11-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High flow nasal cannula (HFNC)
Heated humidified high flow nasal cannula therapy delivered at 2 L/kg/min gas flow rate (for children older than 10 kg in weight, an additional 0.5 L/kg/min per kilogram over 10 kg). Any approved device can be used to deliver HFNC
Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula
A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support
Continuous positive airway pressure (CPAP)
Continuous positive airway pressure delivered using any interface (hood, mask or prongs)
Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support
Interventions
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Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula
A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support
Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support
Eligibility Criteria
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Inclusion Criteria
Group A (Step-up)
1. Age \>36 weeks corrected gestational age and \<16 years, AND
2. Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
3. Satisfies one or more of the following criteria:
* Hypoxia (oxygen saturation \<92% in fraction of inspired oxygen (FiO2) \>0.40, or equivalent). FiO2 of 0.40 roughly equates to standard unhumidified nasal cannula oxygen delivered at 6 L/min or oxygen delivered via facemask without a rebreather bag at 6-10 L/min.
* Acute respiratory acidosis (pH \<7.3 with a concomitant pCO2 \>6.5 kPa)
* Moderate respiratory distress (use of accessory muscles, subcostal and intercostal recession, tachypnoea for age, grunting)
Group B (Step-down)
1. Age \>36 weeks corrected for gestation and \<16 years, AND
2. Deemed to require non-invasive respiratory support by the treating clinician after extubation, following a spell of invasive ventilation
* Either immediately after extubation as a 'planned' procedure, irrespective of clinical condition ('planned') OR
* Prompted by deterioration in clinical condition within 72 hours after extubation ('rescue'). Clinical parameters to assess the need for NRS in this situation will be similar to point 3 in Group A.
Exclusion Criteria
2. Tracheostomy in place
3. Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
4. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
5. Agreed limitation of intensive care treatment plan in place ('not for intubation')
6. On domiciliary non-invasive ventilation prior to PICU admission
7. Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours
8. Previously recruited to this study during the same PICU admission
9. Cannot be treated with HFNC
* Unavailability of appropriate sized nasal prongs
* Unavailability of HFNC device
10. Cannot be treated with CPAP
* Unavailability of right size of face mask, prong or other patient interface
* Unavailability of CPAP device
36 Weeks
15 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Barts & The London NHS Trust
OTHER
Intensive Care National Audit & Research Centre
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Padmanabhan Ramnarayan
Role: PRINCIPAL_INVESTIGATOR
Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)
Locations
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Barts Health NHS Trust
London, , United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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References
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Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter RR, Wulff J, Harrison DA, Mouncey PM, Peters MJ; United Kingdom Paediatric Intensive Care Society Study Group (PICS-SG). FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care. 2018 Jun 4;22(1):144. doi: 10.1186/s13054-018-2080-3.
Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter R, Mouncey P, Peters MJ. FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children. BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181.
Other Identifiers
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14HC30
Identifier Type: -
Identifier Source: org_study_id