scholarly journals The SHINE Trial (A Multicentre, Randomised Trial of Stabilisation with Nasal High Flow During Neonatal Endotracheal Intubation): Statistical Analysis Plan

Author(s):  
Kate Hodgson ◽  
Brett Manley ◽  
Omar Kamlin ◽  
Louise Owen ◽  
Calum Roberts ◽  
...  

Abstract Endotracheal intubation is an essential but potentially destabilising procedure for neonates. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates including desaturation and bradycardia are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy during apnoea extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation [1]. This technique is untested in neonates.

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039230
Author(s):  
Kate A Hodgson ◽  
Louise S Owen ◽  
Camille Omar Kamlin ◽  
Calum T Roberts ◽  
Susan M Donath ◽  
...  

IntroductionNeonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.Methods and analysisThe Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks’ gestation; ≥28 weeks’ gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).Ethics and disseminationThe SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women’s Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.Trial registration numberACTRN12618001498280.


2021 ◽  
Author(s):  
Mathias Johansen ◽  
Sam J. Daniel ◽  
Thomas Engelhardt

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031873
Author(s):  
Susan Humphreys ◽  
Britta Sylvia von Ungern-Sternberg ◽  
Justin Skowno ◽  
Tara Williams ◽  
Julia Taylor ◽  
...  

IntroductionHypoxaemia during anaesthesia for tubeless upper airway surgery in children with abnormal airways is common due to the complexity of balancing adequate depth of anaesthesia with maintenance of spontaneous breathing and providing an uninterrupted field of view of the upper airway for the surgeon. High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW). The aim is to investigate if use of HIGH-FLOW can reduce the number of hypoxaemic events requiring rescue oxygenation compared with LOW-FLOW.Methods and analysisHigh-flow oxygen for children’sairway surgery: randomised controlledtrial (HAMSTER) is a multicentre, unmasked, randomised controlled, parallel group, superiority trial comparing two oxygenation techniques during anaesthesia. Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia. Maintenance of anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA at discretion of anaesthetist. The primary outcome is the incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission. Hypoxaemia is defined as Sp02<90%. Analysis will be conducted on an intention-to-treat basis.Ethics and disseminationEthical approval has been obtained by Children’s Health Queensland Human Research Ethics Committee (HREC/18/QRCH/130). The trial commenced recruitment in 2018. The primary manuscript will be submitted for publication in a peer-reviewed journal.Trial registration numberThe HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.


2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Ricard Mellado-Artigas ◽  
◽  
Luis Eduardo Mujica ◽  
Magda Liliana Ruiz ◽  
Bruno Leonel Ferreyro ◽  
...  

Abstract Purpose We aimed to describe the use of high-flow nasal oxygen (HFNO) in patients with COVID-19 acute respiratory failure and factors associated with a shift to invasive mechanical ventilation. Methods This is a multicenter, observational study from a prospectively collected database of consecutive COVID-19 patients admitted to 36 Spanish and Andorran intensive care units (ICUs) who received HFNO on ICU admission during a 22-week period (March 12-August 13, 2020). Outcomes of interest were factors on the day of ICU admission associated with the need for endotracheal intubation. We used multivariable logistic regression and mixed effects models. A predictive model for endotracheal intubation in patients treated with HFNO was derived and internally validated. Results From a total of 259 patients initially treated with HFNO, 140 patients (54%) required invasive mechanical ventilation. Baseline non-respiratory Sequential Organ Failure Assessment (SOFA) score [odds ratio (OR) 1.78; 95% confidence interval (CI) 1.41-2.35], and the ROX index calculated as the ratio of partial pressure of arterial oxygen to inspired oxygen fraction divided by respiratory rate (OR 0.53; 95% CI: 0.37-0.72), and pH (OR 0.47; 95% CI: 0.24-0.86) were associated with intubation. Hospital site explained 1% of the variability in the likelihood of intubation after initial treatment with HFNO. A predictive model including non-respiratory SOFA score and the ROX index showed excellent performance (AUC 0.88, 95% CI 0.80-0.96). Conclusions Among adult critically ill patients with COVID-19 initially treated with HFNO, the SOFA score and the ROX index may help to identify patients with higher likelihood of intubation.


2018 ◽  
Vol 18 (3) ◽  
pp. 278
Author(s):  
Khaloud S. Al-Mukhaini ◽  
Najwa M. Al-Rahbi

Noninvasive ventilation (NIV) refers to the use of techniques to deliver artificial respiration to the lungs without the need for endotracheal intubation. As NIV has proven beneficial in comparison to invasive mechanical ventilation, it has become the optimal modality for initial respiratory support among children in respiratory distress. High-flow nasal cannulae (HFNC) therapy is a relatively new NIV modality and is used for similar indications. This review discusses the usefulness and applications of conventional NIV in comparison to HFNC.Keywords: Noninvasive Ventilation; Nasal Cannulae; Endotracheal Intubation; Mechanical Ventilation; Children.


2018 ◽  
Vol 46 (12) ◽  
pp. 2010-2017 ◽  
Author(s):  
Martin B. Brodsky ◽  
Matthew J. Levy ◽  
Erin Jedlanek ◽  
Vinciya Pandian ◽  
Brendan Blackford ◽  
...  

2019 ◽  
Author(s):  
Gang-Qiang Sun ◽  
Wen-jun Guo ◽  
Qing Xu ◽  
Chen Liu ◽  
Shang-Ping Fang

Abstract Background: Mechanical ventilation is indispensable in many animal experiments, and establishing a stable airway to control breathing is critical. However, endotracheal intubation in small rodents is very difficult due to the lack of visibility of the epiglottis. In addition, traditional blind endotracheal intubation methods usually cause laryngopharyngeal injury and can even result in death; thus, a noninvasive endotracheal intubation device is needed. Results: The video laryngoscope required significantly less time and fewer attempts to achieve successful intubation. The incidences of vomiting reflex, asphyxia and injury were significantly lower in video laryngoscope group. In addition, the time elapsed until the first feeding postextubation was less in video laryngoscope group, indicating faster recovery. Conclusions: The new video laryngoscope endotracheal intubation device used in this study is simple, noninvasive, safe and practical.


2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Amr Mounir Shoukri

Abstract Background High flow nasal cannula oxygen (HFNCO) is a relatively new technique used to deliver oxygen in respiratory failure patients. This retrospective study is aiming to assess the role and benefits of using HFNCO compared to non-invasive ventilation (NIV) in management of patients with acute hypoxemic respiratory failure associated with coronavirus disease 2019 (COVID-19). Results A retrospective analysis of the files of 63 patients with COVID-19 and acute hypoxemic respiratory failure admitted to the intensive care unit (ICU), 37 patients received HFNCO as initial therapy, and 26 patients were primarily treated with NIV. There was no significant difference between the 2 groups in terms of baseline characteristics, laboratory tests, arterial blood gases, PaO2/FiO2 values, and vital signs. Re-assessment after 24 h of starting treatment with either HFNCO or NIV showed significant improvement (P<0.01) in the respiratory rate, heart rate, and oxygenation parameters. The magnitude of improvement of the vital signs and oxygenation was not significantly different between patients using HFNCO or NIV. Success rate of HFNCO was 86.4%, endotracheal intubation with invasive mechanical ventilation was required in 10.81% of patients, and mortality rate was 2.7%. Success rate of NIV was 84.6%, endotracheal intubation rate was 11.53%, and mortality rate was 3.8%. No significant difference (P>0.05) between the 2 groups as regards the duration of treatment, rate of endotracheal intubation with invasive mechanical ventilation, and mortality rate. Conclusion High flow nasal cannula oxygen (HFNCO) is effective in the management of acute hypoxemic respiratory failure associated with COVID-19. Its efficacy is similar to NIV, with no difference in the duration of treatment, endotracheal intubation rate, or mortality rate.


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