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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.

ABSTRACT: BACKGROUND:Although 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. METHODS:In 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. RESULTS:Overall, 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). CONCLUSIONS:Our 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 REGISTRATION:clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015.

SUBMITTER: Ramnarayan P

PROVIDER: S-EPMC5987627 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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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.

Ramnarayan Padmanabhan P Lister Paula P Dominguez Troy T Habibi Parviz P Edmonds Naomi N Canter Ruth R RR Wulff Jerome J Harrison David A DA Mouncey Paul M PM Peters Mark J MJ

Critical care (London, England) 20180604 1

<h4>Background</h4>Although 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.<h4>Methods</h4>In this multi-centre pilot RCT, eligib ...[more]

PMID: 29866165

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Project description:IntroductionOver 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 analysisWe 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 disseminationEthical 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 numberNCT02612415; pre-results.

Project description:Background: Continuous positive airway pressure (CPAP) has been associated with a lower risk of treatment failure than high-flow nasal cannula (HFNC) in pediatric patients with respiratory distress and severe hypoxemia. However, the publication of new trials on children younger than 2 years warrants a review and updated meta-analysis of the evidence. Methods: We conducted a systematic search in the PubMed, Scopus, and Google scholar databases for randomized controlled trials (RCTs) in pediatric patients with acute respiratory distress that examined outcomes of interest by the two usual management modalities (CPAP and HFNC). We used pooled adjusted relative risks (RRs) to present the strength of association for categorical outcomes and weighted mean differences (WMDs) for continuous outcomes. Results: We included data from six articles in the meta-analysis. The quality of the studies was deemed good. Included studies had infants with either acute viral bronchiolitis or pneumonia. Compared to CPAP, HFNC treatment carried a significantly higher risk of treatment failure [RR, 1.45; 95% CI, 1.06 to 1.99; I 2 = 0.0%, n = 6]. Patients receiving HFNC had a lower risk of adverse events, mainly nasal trauma [RR, 0.30; 95% CI, 0.14 to 0.62; I 2 = 0.0%, n = 2] than the others. The risk of mortality [RR, 3.33; 95% CI, 0.95, 11.67; n = 1] and need for intubation [RR, 1.69; 95% CI, 0.97, 2.94; I 2 = 0.0%, n = 5] were statistically similar between the two management strategies; however, the direction of the pooled effect sizes is indicative of a nearly three times higher mortality and two times higher risk of intubation in those receiving HFNC. We found no statistically significant differences between the two management modalities in terms of modified woods clinical asthma score (M-WCAS; denoting severity of respiratory distress) and hospitalization length (days). Patients receiving HFNC had the time to treatment failure reduced by approximately 3 h [WMD, -3.35; 95% CI, -4.93 to -1.76; I 2 = 0.0%, n = 2] compared to those on CPAP. Conclusions: Among children with respiratory distress younger than 2 years, HFNC appears to be associated with higher risk of treatment failure and possibly, an increased risk of need for intubation and mortality. Adequately powered trials are needed to confirm which management strategy is better.

Project description:Respiratory support is crucial for the survival of preterm infants, and High-flow Nasal Cannula Oxygen Therapy (HFNC) and Continuous Positive Airway Pressure (CPAP) are commonly used for neonatal respiratory support. This meta-analysis aimed to compare the effects of HFNC and CPAP in primary respiratory support for preterm infants, to provide evidence-based support for clinical practice. PubMed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, VIP, WANFANG and SinoMed were searched for eligible studies. The primary outcomes included the incidence of treatment failure and the application of mechanical ventilation. A total of 27 eligible studies with 3,351 participants were included. There was no significant difference in the incidence of respiratory support failure [RR = 1.17, 95%CI (0.88-1.56)] and the application of mechanical ventilation [RR = 1.00, 95%CI (0.84-1.19)] between HFNC group and CPAP group. HFNC resulted in lower rate of air leaks [RR = 0.65, 95%CI (0.46-0.92)], nasal trauma [RR = 0.36, 95%CI (0.29-0.45)] and abdominal distension [RR = 0.39, 95%CI (0.27-0.58)], and later time of mechanical ventilation initiating [SMD = 0.60, 95%CI (0.21-0.99)], less duration of oxygen therapy [SMD = -0.35, 95%CI (-0.68 to -0.02)] and earlier enteral feeding [SMD = -0.54, 95%CI (-0.95 to -0.13)]. Alternative non-invasive respiratory support after initial treatment failure resulted in no difference in the application of mechanical ventilation between the two groups [RR = 0.99, 95%CI (0.52-1.88)]. HFNC might be more effective and safer in primary respiratory support for preterm infants. Using CPAP as a remedy for the treatment failure of HFNC could not avoid intubation. For premature infants with the gestational age <28 weeks, HFNC as primary respiratory support still needs to be further elucidated. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022313479, identifier: CRD42022313479.

Project description:ImportanceRespiratory distress syndrome and feeding intolerance are common conditions that are often associated with preterm infants. Showing similar efficacy, nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) are the most widespread noninvasive respiratory support (NRS) in neonatal intensive care units, but their effect on feeding intolerance is unknown.ObjectiveTo evaluate the effect of NCPAP vs HHHFNC on high-risk preterm infants with respiratory distress syndrome.Design, setting, and participantsThis multicenter randomized clinical trial involved infants who were born in 1 of 13 neonatal intensive care units in Italy between November 1, 2018, and June 30, 2021. Preterm infants with a gestational age of 25 to 29 weeks, who were suitable for enteral feeding and who proved to be medically stable on NRS for at least 48 hours were enrolled in the study within the first week of life and randomized to receive either NCPAP or HHHFNC. Statistical analysis was performed according to the intention-to-treat approach.InterventionNCPAP or HHHFNC.Main outcomes and measuresThe primary outcome was the time to full enteral feeding (FEF), defined as an enteral intake of 150 mL/kg per day. Secondary outcomes were the median daily increment of enteral feeding, signs of feeding intolerance, effectiveness of the assigned NRS, peripheral oxygen saturation (SpO2)-fraction of inspired oxygen (FIO2) ratio at changes of NRS, and growth.ResultsTwo-hundred forty-seven infants (median [IQR] gestational age, 28 [27-29] weeks; 130 girls [52.6%]) were randomized to the NCPAP group (n = 122) or the HHHFNC group (n = 125). There were no differences in the primary and secondary nutritional outcomes between the 2 groups. The median time to reach FEF was 14 days (95% CI, 11-15 days) in the NCPAP group and 14 days (95% CI, 12-18 days) in the HHHFNC group, and similar results were observed in the subgroup of infants with less than 28 weeks' gestation. On the first NRS change, higher SpO2-FIO2 ratio (median [IQR], 4.6 [4.1-4.7] vs 3.7 [3.2-4.0]; P < .001) and lower rate of ineffectiveness (1 [4.8%] vs 17 [73.9%]; P < .001) were observed in the NCPAP vs HHHFNC group.Conclusions and relevanceThis randomized clinical trial found that NCPAP and HHHFNC had similar effects on feeding intolerance, despite different working mechanisms. Clinicians may tailor respiratory care by selecting and switching between the 2 NRS techniques on the basis of respiratory effectiveness and patient compliance, without affecting feeding intolerance.Trial registrationClinicalTrials.gov Identifier: NCT03548324.

Project description:ImportanceThe optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known.ObjectiveTo evaluate the noninferiority of high-flow nasal cannula (HFNC) therapy as the first-line mode of noninvasive respiratory support following extubation, compared with continuous positive airway pressure (CPAP), on time to liberation from respiratory support.Design, setting, and participantsThis was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive respiratory support within 72 hours of extubation were recruited between August 8, 2019, and May 18, 2020, with last follow-up completed on November 22, 2020.InterventionsPatients were randomized 1:1 to start either HFNC at a flow rate based on patient weight (n = 299) or CPAP of 7 to 8 cm H2O (n = 301).Main outcomes and measuresThe primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were 6 secondary outcomes, including mortality at day 180 and reintubation within 48 hours.ResultsOf the 600 children who were randomized, 553 children (HFNC, 281; CPAP, 272) were included in the primary analysis (median age, 3 months; 241 girls [44%]). HFNC failed to meet noninferiority, with a median time to liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) for CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞). Similar results were seen across prespecified subgroups. Of the 6 prespecified secondary outcomes, 5 showed no significant difference, including the rate of reintubation within 48 hours (13.3% for HFNC vs 11.5 % for CPAP). Mortality at day 180 was significantly higher for HFNC (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 [95% CI, 1.1-8.8]). The most common adverse events were abdominal distension (HFNC: 8/281 [2.8%] vs CPAP: 7/272 [2.6%]) and nasal/facial trauma (HFNC: 14/281 [5.0%] vs CPAP: 15/272 [5.5%]).Conclusions and relevanceAmong critically ill children requiring noninvasive respiratory support following extubation, HFNC compared with CPAP following extubation failed to meet the criterion for noninferiority for time to liberation from respiratory support.Trial registrationisrctn.org Identifier: ISRCTN60048867.

Project description:BackgroundOptimal flow settings during high-flow nasal cannula (HFNC) therapy are unknown. We investigated the optimal flow settings during HFNC therapy based on breathing pattern and tidal inspiratory flows in patients with acute hypoxemic respiratory failure (AHRF).MethodsWe conducted a prospective clinical study in adult hypoxemic patients treated by HFNC with a fraction of inspired oxygen (FIO2) ≥ 0.4. Patient's peak tidal inspiratory flow (PTIF) was measured and HFNC flows were set to match individual PTIF and then increased by 10 L/min every 5-10 min up to 60 L/min. FIO2 was titrated to maintain pulse oximetry (SpO2) of 90-97%. SpO2/FIO2, respiratory rate (RR), ROX index [(SpO2/FIO2)/RR], and patient comfort were recorded after 5-10 min on each setting. We also conducted an in vitro study to explore the relationship between the HFNC flows and the tracheal FIO2, peak inspiratory and expiratory pressures.ResultsForty-nine patients aged 58.0 (SD 14.1) years were enrolled. At enrollment, HFNC flow was set at 45 (38, 50) L/min, with an FIO2 at 0.62 (0.16) to obtain an SpO2/FIO2 of 160 (40). Mean PTIF was 34 (9) L/min. An increase in HFNC flows up to two times of the individual patient's PTIF, incrementally improved oxygenation but the ROX index plateaued with HFNC flows of 1.34-1.67 times the individual PTIF. In the in vitro study, when the HFNC flow was set higher than PTIF, tracheal peak inspiratory and expiratory pressures increased as HFNC flow increased but the FIO2 did not change.ConclusionMean PTIF values in most patients with AHRF were between 30 and 40 L/min. We observed improvement in oxygenation with HFNC flows set above patient PTIF. Thus, a pragmatic approach to set optimal flows in patients with AHRF would be to initiate HFNC flow at 40 L/min and titrate the flow based on improvement in ROX index and patient tolerance.Trial registrationClinicalTrials.gov (NCT03738345). Registered on November 13th, 2018. https://clinicaltrials.gov/ct2/show/NCT03738345?term=NCT03738345&draw=2&rank=1.

Dataset Information

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.

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.

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