scholarly journals FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038002 ◽  
Author(s):  
Alvin Richards-Belle ◽  
Peter Davis ◽  
Laura Drikite ◽  
Richard Feltbower ◽  
Richard Grieve ◽  
...  
Keyword(s):  
Critical Care ◽  
Continuous Positive Airway Pressure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
High Flow ◽  
Respiratory Support ◽  
High Flow Nasal Cannula ◽  
First Line ◽  
Non Invasive ◽  
Paediatric Critical Care

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

Efficacy of Nasal Continuous Positive Airway Pressure versus Heated Humidified High-Flow Nasal Cannula as a Primary Mode of Respiratory Support in Preterm Infants with RDS

2021 ◽  
Vol 17 (3) ◽  
pp. 246-250
Author(s):  
Qaiser Zaman ◽  
Syeda Shireen Gul ◽  
Muhammad Hayat Khan ◽  
Sehrish Noor
Keyword(s):  
Continuous Positive Airway Pressure ◽  
Treatment Failure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Total Duration ◽  
High Flow ◽  
Respiratory Support ◽  
High Flow Nasal Cannula ◽  
Supplementary Oxygen ◽  
Non Invasive

Objective: To determine the efficacy of nasal continuous positive airway pressure (NCPAP) versus heated humidified high-flow nasal cannula (HHHFNC) as a primary mode of respiratory support in preterm infants with respiratory distress. Methodology: This randomized controlled trial study was conducted at in-patient department of neonatology (Nursery & NICU) of Pakistan Insitute of Medical Sciences (PIMS) from July 2020 to Dec 2020. A total of 280 neonates randomly divided (140 in each study group) of both genders, with gestational age between 28-34 weeks and having mild-to-moderate respiratory distress within 1st 6 hours of birth requiring non-invasive ventilation were enrolled. Neonates in NCPAP Group (n=140) were given NCPAP whereas neonates in HHHFNC Group (n=140) were given HHHFNC. The efficacy of both groups were compared on the basis of treatment failure within 1st 3 days, total duration (hours) of non-invasive ventilator (NIV) required and total duration (hours) of supplementary oxygen required. Results: Overall, mean gestational age was noted to be 30.0+6.4 weeks. There were 144 (51.4%) neonates with birth weight between 1 to 1.4 kg, 90 (32.1%) between 1.5 to 1.9 kg and 46 (16.4%0 between 2.0 to 2.4 kg. Treatment failure was noted in 67 (47.6%) neonates in NCAP group while HHHFNC group reported 73 (52.4%) neonates with treatment failure (p=0.4733). No significant difference was observed in mean total duration of NIV support required (p=0.2598) or mean total duration of supplementary oxygen (p=0.1946) in between study groups. Conclusion: HHHFNC had similar efficacy when compared to NCPAP among neonates with RDS. In comparison to NCPAP, HHHFNC could be a simple, well-tolerated and effective alternative in terms of respiratory support. No major difference in terms of complication was observed between both treatment approaches.

Comparison between Continuous positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) in Management of Bronchiolitis and community acquired pneumonia in Infants and Young Children

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Tarek Ahmed Abdel Gawad ◽  
Ahmad Mostafa Allam ◽  
Sarah Ali El Sayed
Keyword(s):  
Respiratory Failure ◽  
Continuous Positive Airway Pressure ◽  
Acute Respiratory Failure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Community Acquired Pneumonia ◽  
High Flow ◽  
Nasal Cannula ◽  
Respiratory Support ◽  
High Flow Nasal Cannula

Abstract Background Acute respiratory failure develops in infants with bronchiolitis and Community acquired pneumonia (CAP) because of hypoxemia, due to mismatch between ventilation and perfusion. Nasal continuous airway pressure (nCPAP) and high-flow nasal cannula (HFNC) improve the work of breathing and oxygenation .High flow nasal cannula (HFNC), also called heated humidified high flow nasal cannula (HHHFNC), is a new non-invasive ventilation therapy that seems to be well tolerated in infants with hypoxemic respiratory failure. Aim To compare the effectiveness and the outcome of Heated Humidified High Flow Nasal Cannula (HFNC) versus Nasal Continuous Positive Airway Pressure (NCPAP), as a primary mode of respiratory support, in patients with respiratory failure due to pneumonia or bronchiolitis at PICU regarding demographic data, length of admission, increasing of positive pressure and need of intubation. Patients and Methods observational study was conducted on 40 patients with acute respiratory failure due to either bronchiolitis or community acquired pneumonia (CAP), admitted to Paediatric ICU, Children Hospital, Ain Shams University, in the time period between February 2018 to July 2019. The patients, aged between 1 month to 5 years, were subjected to detailed clinical history and examination.All patients received continuous monitoring of electrocardiograph ,pulse oximetry and respiratory rate .The patients were treated either with (HFNC) Humidified high flow nasal cannula or continuous positive airway pressure (CPAP). Studied groups were compared regarding demographic data, increasing in respiratory support ,need of intubation, fate and length of admission during PICU stay. Results HFNC was as efficient as CPAP in lowering RR(respiratory rate) and HR(heart rate) in infants with bronchiolitis and community acquired pneumonia. Thus HFNC group was as significant as NCPAP group in treatment of bronchiolitis and CAP regarding length of admission ,increasing of positive pressure and need of iintubation in PICU . Conclusion This study concluded that HFNC is as efficient as nCPAP for initial respiratory support in young infants, hospitalized in a PICU for moderate to severe acute respiratory failure.

scholarly journals 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

Critical Care ◽  
2018 ◽  
Vol 22 (1) ◽  
Author(s):  
Padmanabhan Ramnarayan ◽  
◽  
Paula Lister ◽  
Troy Dominguez ◽  
Parviz Habibi ◽  
...  
Keyword(s):  
Critical Care ◽  
Positive Airway Pressure ◽  
High Flow Nasal Cannula ◽  
First Line ◽  
Non Invasive ◽  
Pilot Rct ◽  
Group A ◽  
Group B ◽  
Randomised Controlled ◽  
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.

Systematic review of high-flow nasal cannula versus continuous positive airway pressure for primary support in preterm infants

2021 ◽  
pp. fetalneonatal-2020-321094
Author(s):  
Shaam Bruet ◽  
Marine Butin ◽  
Frederic Dutheil
Keyword(s):  
Continuous Positive Airway Pressure ◽  
Treatment Failure ◽  
Preterm Infants ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Meta Analysis ◽  
High Flow ◽  
Respiratory Support ◽  
High Flow Nasal Cannula ◽  
Nasal Trauma

IntroductionWe conducted a meta-analysis of trials that compared efficacy and safety of high-flow nasal cannula (HFNC) with continuous positive airway pressure (CPAP) as primary respiratory support in preterm infants and a study of the impact of clinical relevant parameters.MethodsDatabases were searched for randomised controlled trials comparing HFNC with CPAP as primary respiratory support in preterm infants. Treatment failure was considered as primary outcome and adverse events as secondary outcomes. We calculated risk ratios (RRs) in intention-to-treat analysis and random-effects meta-analyses of risks were conducted.ResultsWe included 10 studies for a total of 1830 patients. Meta-analysis demonstrated an RR of treatment failure multiplied by 1.34 using HFNC compared with CPAP (RR=1.34, 95% CI 1.01 to 1.68, I2=16.2%). Secondary outcome meta-analysis showed no difference in intubation rates (RR=0.90, 95% CI 0.66 to 1.15) and a lower rate of nasal trauma using HFNC compared with CPAP (RR=0.48, 95% CI 0.31 to 0.65, I²=0.0%). Meta-regressions did not show any influence of gestational age and weight at birth, HFNC flow rate, type of CPAP generator or use of surfactant.ConclusionsDespite a higher risk of treatment failure, considering no difference in intubation rates and a lower rate of nasal trauma using HFNC compared with CPAP, we suggest that HFNC should be used as primary respiratory support in preterm infants.

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