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

Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy E.; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth R; Mouncey, Paul; Peters, Mark

doi:10.1136/bmjopen-2017-016181

Cited by 11 publications

(4 citation statements)

References 38 publications

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“…A detailed description of the Methods has been published previously [ 32 ]. The study protocol is available at https://www.icnarc.org/Our-Research/Studies/First-Abc/Study-Documents .…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2018

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BackgroundAlthough high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care.MethodsIn this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT.ResultsOverall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2).ConclusionsOur pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients.Trial registrationclinicaltrials.gov, NCT02612415. Registered on 23 November 2015.Electronic supplementary materialThe online version of this article (10.1186/s13054-018-2080-3) contains supplementary material, which is available to authorized users.

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“…A detailed description of the Methods has been published previously [ 32 ]. The study protocol is available at https://www.icnarc.org/Our-Research/Studies/First-Abc/Study-Documents .…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2018

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“…The use of HFNC therapy is increasing, 1,2 but the cost and health care outcomes of this invasive therapy remain ill-defined in the paediatric population. The ease of use appears to be one of the primary reasons why this therapy has become widely used 3 ; it has been shown to be safe 17 and is well tolerated 18 compared with the nasal masks/prongs used for CPAP, which are more challenging to maintain in children 19 and may cause skin integrity complications. 8 While HFNC therapy is recognized as an effective first-line therapy in children whose respiratory state is deteriorating, with the aim of reducing the need for intubation, 15,20 the indications and efficacy for it to improve outcomes following extubation are not well understood; in particular, there remain concerns about the efficacy of pressure delivery compared with traditional CPAP in children.…”

Section: Discussionmentioning

confidence: 99%

“…The use of HFNC therapy is increasing, 1,2 but the cost and health care outcomes of this invasive therapy remain ill‐defined in the paediatric population. The ease of use appears to be one of the primary reasons why this therapy has become widely used 3 ; it has been shown to be safe 17 and is well tolerated 18 compared with the nasal masks/prongs used for CPAP, which are more challenging to maintain in children 19 and may cause skin integrity complications 8 …”

Section: Discussionmentioning

confidence: 99%

Predicting use of high‐flow nasal cannula therapy following extubation in paediatrics

White

Daubney

Harvey

et al. 2020

Nursing in Critical Care

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Background High‐flow nasal cannula (HFNC) therapy is widely used for respiratory support within paediatrics, most commonly used as a supportive measure in acute respiratory failure, aiming to avoid invasive mechanical ventilation (IMV). It is increasingly being used following extubation of critically ill children potentially at a higher risk of requiring re‐intubation. Less data indicate the use for post‐extubation HFNC therapy or possible clinical outcomes of this therapy. Aims and objectives To identify reasons for, and variables to predict, the use of HFNC therapy post‐extubation. Design This was a retrospective case‐control study. Methods All children admitted to a nine‐bedded regional paediatric intensive care unit requiring IMV between 18 December 2017 and 28 November 2018 were identified. The demographic data and bedside clinical and laboratory variables of the patients requiring HFNC therapy were compared with those who did not require HFNC. Results There was no statistical difference in the median age and weight of children receiving HFNC therapy post‐extubation compared with children not receiving it. In a logistic regression model, the highest ventilation (peak inspiratory pressure) and oxygen requirements in the first 24 hours of admission, along with the presence of comorbidity and use of HFNC therapy prior to intubation, predicted the use of HFNC following extubation, (r2 0.42, area under the receiver operating curve 0.843, P < .0001). Conclusions The direct correlation between high initial ventilatory requirements and pre‐existing comorbidity was significant for the use of post‐extubation HFNC therapy. This may be useful to stratify children in the use of HFNC therapy post‐extubation in the critically ill population. Relevance to clinical practice This study provides evidence that it may be possible to predict the use of HFNC therapy post‐extubation. Avoiding unnecessary use of this therapy improves patient care while providing a positive economic impact.

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“…As CSE is a medical emergency a deferred consent model will be used, with consent sought once the child’s clinical condition has stabilised. This approach has been successfully used in previous paediatric ED trials [ 8 , 26 ]. A research nurse or other designated member of the research team will approach the person with parental responsibility/representative/patient to seek consent as soon as is reasonable based on the patient’s clinical condition, based on the opinion of the clinical team (ideally within 24 h of randomisation).…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT))

Forsyth,

Allen,

Bedson

et al. 2024

Trials

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Background Paediatric convulsive status epilepticus is the most common neurological emergency presenting to emergency departments. Risks of resultant neurological morbidity and mortality increase with seizure duration. If the seizure fails to stop within defined time-windows, standard care follows an algorithm of stepwise escalation to more intensive treatments, ultimately resorting to induction of general anaesthesia and ventilation. Additionally, ventilatory support may also be required to treat respiratory depression, a common unwanted effect of treatment. There is strong pre-clinical evidence that pH (acid–base balance) is an important determinant of seizure commencement and cessation, with seizures tending to start under alkaline conditions and terminate under acidic conditions. These mechanisms may be particularly important in febrile status epilepticus: prolonged fever-related seizures which predominantly affect very young children. This trial will assess whether imposition of mild respiratory acidosis by manipulation of inhaled medical gas improves response rates to first-line medical treatment. Methods A double-blind, placebo-controlled trial of pH manipulation as an adjunct to standard medical treatment of convulsive status epilepticus in children. The control arm receives standard medical management whilst inhaling 100% oxygen; the active arm receives standard medical management whilst inhaling a commercially available mixture of 95% oxygen, 5% carbon dioxide known as ‘carbogen’. Due to the urgent need to treat the seizure, deferred consent is used. The primary outcome is success of first-line treatment in seizure cessation. Planned subgroup analyses will be undertaken for febrile and non-febrile seizures. Secondary outcomes include rates of induction of general anaesthesia, admission to intensive care, adverse events, and 30-day mortality. Discussion If safe and effective 95% oxygen, 5% carbon dioxide may be an important adjunct in the management of convulsive status epilepticus with potential for pre-hospital use by paramedics, families, and school staff. Trial registration EudraCT: 2021-005367-49. CTA: 17136/0300/001. ISRCTN: 52731862. Registered on July 2022.

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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

Cited by 11 publications

References 38 publications

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

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

Predicting use of high‐flow nasal cannula therapy following extubation in paediatrics

Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT))

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