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A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol

ABSTRACT: Introduction Neonatal 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 analysis The 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 dissemination The 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 number ACTRN12618001498280.

SUBMITTER: Hodgson K

PROVIDER: S-EPMC7537449 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe benefits of high-flow nasal cannula (HFNC) as primary intervention in patients with acute hypoxemic respiratory failure (AHRF) are still a matter in debate. Our objective was to compare HFNC therapy versus conventional oxygen therapy (COT) in the prevention of endotracheal intubation in this group of patients.MethodsAn open-label, controlled and single-centre clinical trial was conducted in patients with severe AHRF, defined by a PaO2/FIO2 ratio ⩽200, to compare HFNC with a control group (CG) treated by COT delivered through a face mask, with the need to perform intubation as the primary outcome. The secondary outcomes included tolerance of the HFNC device and to look for the predictive factors for intubation in these patients.ResultsA total of 46 patients were included (22 in the COT group and 24 in the HFNC group) 48% of whom needed intubation: 63% in the COT group and 33% in the HFNC group, with significant differences both in intention to treat [χ2 = 4.2; p = 0.04, relative risk (RR) = 0.5; confidence interval (CI) 95%: 0.3-1.0] and also in treatment analysis (χ2 = 4.7; p = 0.03; RR = 0.5; IC 95%: 0.3-0.9) We obtained a number needed to treat (NNT) = 3 patients treated to avoid an intubation. Intubation occurred significantly later in the HFNC group. Estimated PaO2/FIO2, respiratory rate and dyspnea were significantly better in the HFNC group. Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients. Mortality was 22% with no differences. The HFNC group patients were hospitalized for almost half of the time in the intensive care unit (ICU) and in the ward, with significantly less hospital length of stay. A total of 14 patients in the HFNC group (58%) complained of excessive heat and 17% of noise; 3 patients did not tolerate HFNC.ConclusionPatients with severe acute hypoxemic respiratory failure who tolerate HFNC present a significantly lower need for endotracheal intubation compared with conventional oxygen therapy.Clinical trial registerEUDRA CT number: 2012-001671-36The reviews of this paper are available via the supplemental material section.

Project description:BackgroundThe benefit-risk ratio of prophylactic non-invasive ventilation (NIV) and high-flow nasal oxygen therapy (HFNC-O2) during the early stage of blunt chest trauma remains controversial because of limited data. The main objective of this study was to compare the rate of endotracheal intubation between two NIV strategies in high-risk blunt chest trauma patients.MethodsThe OptiTHO trial was a randomized, open-label, multicenter trial over a two-year period. Every adult patients admitted in intensive care unit within 48 h after a high-risk blunt chest trauma (Thoracic Trauma Severity Score ≥ 8), an estimated PaO2/FiO2 ratio < 300 and no evidence of acute respiratory failure were eligible for study enrollment (Clinical Trial Registration: NCT03943914). The primary objective was to compare the rate of endotracheal intubation for delayed respiratory failure between two NIV strategies: i) a prompt association of HFNC-O2 and "early" NIV in every patient for at least 48 h with vs. ii) the standard of care associating COT and "late" NIV, indicated in patients with respiratory deterioration and/or PaO2/FiO2 ratio ≤ 200 mmHg. Secondary outcomes were the occurrence of chest trauma-related complications (pulmonary infection, delayed hemothorax or moderate-to-severe ARDS).ResultsStudy enrollment was stopped for futility after a 2-year study period and randomization of 141 patients. Overall, 11 patients (7.8%) required endotracheal intubation for delayed respiratory failure. The rate of endotracheal intubation was not significantly lower in patients treated with the experimental strategy (7% [5/71]) when compared to the control group (8.6% [6/70]), with an adjusted OR = 0.72 (95%IC: 0.20-2.43), p = 0.60. The occurrence of pulmonary infection, delayed hemothorax or delayed ARDS was not significantly lower in patients treated by the experimental strategy (adjusted OR = 1.99 [95%IC: 0.73-5.89], p = 0.18, 0.85 [95%IC: 0.33-2.20], p = 0.74 and 2.14 [95%IC: 0.36-20.77], p = 0.41, respectively).ConclusionA prompt association of HFNC-O2 with preventive NIV did not reduce the rate of endotracheal intubation or secondary respiratory complications when compared to COT and late NIV in high-risk blunt chest trauma patients with non-severe hypoxemia and no sign of acute respiratory failure.Clinical trial registrationNCT03943914, Registered 7 May 2019.

Project description:BackgroundsHigh flow nasal cannula (HFNC) is an alternative therapy for acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19). This study aimed first to describe outcomes of patients suffering from COVID-19-related ARDS treated with HFNC; secondly to evaluate safety of HFNC (patients and healthcare workers) and compare patients according to respiratory outcome.MethodsA retrospective cohort was conducted in French general hospital intensive care unit (ICU). Patients were included if receiving HFNC for hypoxemia (saturation pulse oxygen (SpO2) <92% under oxygen ⩾6 L/min) associated with ARDS and positive SARS-CoV-2 polymerase chain reaction (PCR). Main clinical characteristics and outcomes are described in patients: (a) with do not intubate order (HFNC-DNIO); (b) who did not need intubation (HFNC-only); and (c) eventually intubated (HFNC-intubation). Medians are presented with (1st-3rd) interquartile range.ResultsFrom 26 February to 30 June 2020, 46 patients of median age 75 (70-79) years were included. In the HFNC-DNIO group (n = 11), partial arterial oxygen pressure (PaO2)/inhaled fraction of oxygen (FiO2) ratio median worst PaO2/FiO2 ratio was 109 (102-172) and hospital mortality was 54.5%. Except the HFNC-DNIO patients (n = 35), 20 patients (57%) were eventually intubated (HFNC-intubation group) and 15 were only treated by HFNC (HFNC-only). HFNC-intubation patients presented higher worst respiratory rates per minute in ICU [37 (34-41) versus 33 (24-34) min, p < 0.05] and worsened ICU admission PaO2/FiO2 ratios [121 (103-169) versus 191 (162-219), p < 0.001] compared with HFNC-only patients. Hospital mortality was 35% (n = 7/20) in HFNC-intubation group, 0% in HFNC-only group with a global mortality of these two groups of 20% (n = 7/35). Among tests performed in healthcare workers, 1/12 PCR in symptomatic healthcare workers and 1.8% serologies in asymptomatic healthcare workers were positive. After review of each case, COVID-19 was likely to be acquired outside hospital.ConclusionsHFNC seems to be useful for COVID-19-related ARDS and safe for healthcare workers. ARDS severity with PaO2/FiO2 <150 associated with respiratory rate >35/min could be regarded as a predictor of intubation.The reviews of this paper are available via the supplemental material section.

Project description:IntroductionTracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.Methods and analysisThe endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.Ethics and disseminationThe study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.Trial registration detailsClinicalTrials.gov Identifier: NCT04079387; Pre-results.

Project description:IntroductionApnoeic oxygenation is a process of delivering continuous oxygen through nasal cannula during direct laryngoscopy. The oxygen that is delivered through these nasal cannulas is either low flow or high flow. Although the effectiveness of apnoeic oxygenation has been shown through systematic reviews and randomised controlled trials, a comparison of high-flow versus low-flow oxygen delivery has not been tested through a superiority study design. In this study we propose to assess the effectiveness of giving low-flow oxygen with head side elevation versus high-flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy.Methods and analysisThis will be a three-arm study instituting a block randomisation technique with a sample size of 46 in each arm (see table 1). Due to the nature of the intervention, no blinding will be introduced. The primary outcomes will be lowest non-invasive oxygen saturation measurement during direct laryngoscopy and during the 2 min after the placement of the tube and the first pass success rate. The intervention constitutes head side elevation up to 30° for improving glottis visualisation together with low-flow or high-flow oxygen delivery through nasal cannula to increase safe apnoea time for participants undergoing endotracheal intubation. Primary analysis will be intention to treat.Ethics and disseminationThe study is approved by the Ethical Review Committee of Aga Khan University Hospital (2019-0726-2463). The project is an institution University Research Committee grant recipient 192 002ER-PK. The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails. Further, the findings will be published in a highly accessed peer-reviewed medical journal and will be presented at both national and international conferences.Trial registration numberClinicalTrials.gov Registry (NCT04242537).

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A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol

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