Dataset Information

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.

ABSTRACT:

Introduction

Over 18?000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effectiveness. This feasibility study aims to inform the design and conduct of a future definitive randomised clinical trial (RCT) comparing the two modes of respiratory support.

Methods and analysis

We will conduct a three-centre randomised feasibility study over 12 months. Patients admitted to participating PICUs who satisfy eligibility criteria will be recruited to either group A (primary respiratory failure) or group B (postextubation). Consent will be obtained from parents/guardians prior to randomisation in 'planned' group B, and deferred in emergency situations (group A and 'rescue' group B). Participants will be randomised (1:1) to either CPAP or HFNC using sealed, opaque envelopes, from a computer-generated randomisation sequence with variable block sizes. The study protocol specifies algorithms for the initiation, maintenance and weaning of HFNC and CPAP. The primary outcomes are related to feasibility, including the number of eligible patients in each group, feasibility of randomising >50% of eligible patients and measures of adherence to the treatment protocols. Data will also be collected on patient outcomes (eg, mortality and length of PICU stay) to inform the selection of an appropriate outcome measure in a future RCT. We aim to recruit 120 patients to the study.

Ethics and dissemination

Ethical approval was granted by the National Research Ethics Service Committee North East-Tyne&Wear South (15/NE/0296). Study findings will be disseminated through peer-reviewed journals, national and international conferences.

Trials registration number

NCT02612415; pre-results.

SUBMITTER: Ramnarayan P

PROVIDER: S-EPMC5541500 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 P Lister Paula P Dominguez Troy T Habibi Parviz P Edmonds Naomi N Canter Ruth R Mouncey Paul P Peters Mark J MJ

BMJ open 20170612 6

<h4>Introduction</h4>Over 18 000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effe ...[more]

PMID: 28606907

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Project description: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.

Project description:OBJECTIVES:To derive and validate a score that correlates with an objective measurement of a child's effort of breathing. DESIGN:Secondary analysis of a previously conducted observational study. SETTING:The pediatric and cardiothoracic ICUs of a quaternary-care children's hospital. PATIENTS:Patients more than 37 weeks gestational age to age 18 years who were undergoing extubation. INTERVENTIONS:Effort of breathing was measured in patients following extubation using esophageal manometry to calculate pressure rate product. Simultaneously, members of a multidisciplinary team (nurse, physician, and respiratory therapist) assessed respiratory function using a previously validated tool. Elements of the tool that were significantly associated with pressure rate product in univariate analysis were identified and included in a multivariate model. An Effort of Breathing score was derived from the results of the model using data from half of the subjects (derivation cohort) and then validated using data from the remaining subjects (validation cohort) by calculating the area under the receiver operator characteristic curve for pressure rate product greater than 90th percentile and for the need for reintubation. MEASUREMENTS AND MAIN RESULTS:Among 409 subjects, the median age was 5 months, and nearly half were cardiac surgery patients (49.1%). Retractions, stridor, and pulsus paradoxus were included in the Simple Score. Area under the receiver operator characteristic curve for pressure rate product greater than 90th percentile was 0.8359 (95% CI, 0.7996-0.8722) in the derivation cohort and 0.7930 (0.7524-0.8337) in the validation cohort. Area under the receiver operator characteristic curve for reintubation was 0.7280 (0.6807-0.7752) when all scores were analyzed individually and was 0.7548 (0.6644-0.8452) if scores from three clinicians from different disciplines were summated. Results were similar regardless of provider discipline or training. CONCLUSIONS:A scoring system was derived and validated, performed acceptably to predict increased effort of breathing or need for advanced respiratory support and may function best when used by a team.

Project description:IntroductionEarly enteral nutrition is recommended for critically ill children, potentially exposing those who are undernourished to the risk of refeeding syndrome. However, data on its incidence is lacking, and the heterogeneity of diagnostic criteria and frequent electrolyte disorders in this population make its diagnosis complex. In 2020, the American Society for Parenteral and Enteral Nutrition (ASPEN) developed consensus recommendations for identifying patients at risk and with refeeding syndrome. These state that undernourished children are considered at risk of refeeding syndrome; those who develop one significant electrolyte disorder (decrease ≥ 10% in phosphorus, potassium, and/or magnesium) within the first five days of nutritional support, combined with a significant increase in energy intake, are considered to have refeeding syndrome. The aim of this study was to determine the incidence of refeeding syndrome according to the ASPEN definition in critically ill children on nutritional support.Materials and methodsA secondary analysis of two prospective cohorts conducted in a tertiary pediatric intensive care unit in France was undertaken, and additional data were retrospectively collected. Children included were those (0-18 years) admitted to the pediatric intensive care unit with a minimum of one phosphorus, potassium, and/or magnesium assay and who received exclusive or supplemental nutritional support. Undernourished children (body mass index z-score < -2 standard deviations) were considered at risk of refeeding syndrome. The ASPEN critiera were used to identify those with probable refeeding syndrome.ResultsA total of 1,261 children were included in the study, with 199 children (15.8%) classified as undernourished, who were at risk of refeeding syndrome. Of these, 93 children were identified as having probable refeeding syndrome, giving an overall incidence of 7.4%. The incidence rate among at-risk children was 46.7%. Most patients (58.1%) were classified as having severe refeeding syndrome.ConclusionRefeeding syndrome remains difficult to diagnose in critically ill children, due to frequent confounding factors impacting electrolyte plasma levels. These findings suggest that refeeding syndrome incidence may be high in undernourished children, and that refeeding syndromes can be severe. Further prospective studies using the ASPEN definition and risk criteria are required.

Project description:IntroductionEven though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.Methods and analysisWe will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one sided) to exclude the prespecified non-inferiority margin of HR of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations.Ethics and disseminationThis master protocol received favourable ethical opinion from National Health Service East of England-Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.Trial registration numberISRCTN60048867.

Project description:ObjectiveSevere traumatic brain injury is a significant cause of morbidity and mortality in young adults. Assessing long-term neurological outcome after such injury is difficult and often characterised by uncertainty. The objective of this feasibility study was to establish the feasibility of conducting a large, multicentre prospective study to develop a prognostic model of long-term neurological outcome in critically ill patients with severe traumatic brain injury.DesignA prospective cohort study.Setting9 Canadian intensive care units enrolled patients suffering from acute severe traumatic brain injury. Clinical, biological, radiological and electrophysiological data were systematically collected during the first week in the intensive care unit. Mortality and functional outcome (Glasgow Outcome Scale extended) were assessed on hospital discharge, and then 3, 6 and 12?months following injury.OutcomesThe compliance to protocolised test procedures was the primary outcome. Secondary outcomes were enrolment rate and compliance to follow-up.ResultsWe successfully enrolled 50 patients over a 12-month period. Most patients were male (80%), with a median age of 45?years (IQR 29.0-60.0), a median Injury Severity Score of 38 (IQR 25-50) and a Glasgow Coma Scale of 6 (IQR 3-7). Mortality was 38% (19/50) and most deaths occurred following a decision to withdraw life-sustaining therapies (18/19). The main reasons for non-enrolment were the time window for inclusion being after regular working hours (35%, n=23) and oversight (24%, n=16). Compliance with protocolised test procedures ranged from 92% to 100% and enrolment rate was 43%. No patients were lost to follow-up at 6?months and 2 were at 12?months.ConclusionsIn this multicentre prospective feasibility study, we achieved feasibility objectives pertaining to compliance to test, enrolment and follow-up. We conclude that the TBI-Prognosis prospective multicentre study in severe traumatic brain injury patients in Canada is feasible.

Project description:Predicting whether an obese critically ill patient can be successfully extubated may be specially challenging. Several weaning tests have been described but no physiological study has evaluated the weaning test that would best reflect the post-extubation inspiratory effort.This was a physiological randomized crossover study in a medical and surgical single-center Intensive Care Unit, in patients with body mass index (BMI) >35 kg/m2 who were mechanically ventilated for more than 24 h and underwent a weaning test. After randomization, 17 patients were explored using five settings : pressure support ventilation (PSV) 7 and positive end-expiratory pressure (PEEP) 7 cmH2O; PSV 0 and PEEP 7cmH2O; PSV 7 and PEEP 0 cmH2O; PSV 0 and PEEP 0 cmH2O; and a T piece, and after extubation. To further minimize interaction between each setting, a period of baseline ventilation was performed between each step of the study. We hypothesized that the post-extubation work of breathing (WOB) would be similar to the T-tube WOB.Respiratory variables and esophageal and gastric pressure were recorded. Inspiratory muscle effort was calculated as the esophageal and trans-diaphragmatic pressure time products and WOB. Sixteen obese patients (BMI 44 kg/m2?±?8) were included and successfully extubated. Post-extubation inspiratory effort, calculated by WOB, was 1.56 J/L?±?0.50, not statistically different from the T piece (1.57 J/L?±?0.56) or PSV 0 and PEEP 0 cmH2O (1.58 J/L?±?0.57), whatever the index of inspiratory effort. The three tests that maintained pressure support statistically underestimated post-extubation inspiratory effort (WOB 0.69 J/L?±?0.31, 1.15 J/L?±?0.39 and 1.09 J/L?±?0.49, respectively, p?<?0.001). Respiratory mechanics and arterial blood gases did not differ between the five tests and the post-extubation condition.In obese patients, inspiratory effort measured during weaning tests with either a T-piece or a PSV 0 and PEEP 0 was not different to post-extubation inspiratory effort. In contrast, weaning tests with positive pressure overestimated post-extubation inspiratory effort.Clinical trial.gov (reference NCT01616901 ), 2012, June 4th.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trials registration number

Publications

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.

Similar Datasets

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