Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a statistical analysis plan for a randomised controlled trial

Published online: 31 May 2023The placement of an endotracheal tube for children with acute or critical illness is a low-frequency and high-risk procedure, associated with high rates of first-attempt failure and adverse events, including hypoxaemia. To reduce the frequency of these adverse events, the provision of oxygen to the patient during the apnoeic phase of intubation has been proposed as a method to prolong the time available for the operator to insert the endotracheal tube, prior to the onset of hypoxaemia. However, there are limited data from randomised controlled trials to validate the efficacy of this technique in children. The technique known as transnasal humidified rapid insufflation ventilatory exchange (THRIVE) uses high oxygen flow rates (approximately 2 L/kg/min) delivered through nasal cannulae during apnoea. It has been shown to at least double the amount of time available for safe intubation in healthy children undergoing elective surgery. The technique and its application in real time have not previously been studied in acutely ill or injured children presenting to the emergency department or admitted to an intensive care unit. The Kids THRIVE trial is a multicentre, international, randomised controlled trial (RCT) in children less than 16 years old undergoing emergent intubation in either the intensive care unit or emergency department of participating hospitals. Participants will be randomised to receive either the THRIVE intervention or standard care (no apnoeic oxygenation) during their intubation. The primary objective of the trial is to determine if the use of THRIVE reduces the frequency of oxygen desaturation and increases the frequency of first-attempt success without hypoxaemia in emergent intubation of children compared with standard practice. The secondary objectives of the study are to assess the impact of the use of THRIVE on the rate of adverse events, length of mechanical ventilation and length of stay in intensive care. In this paper, we describe the detailed statistical analysis plan as an update of the previously published protocol.Shane George, Kristen Gibbons, Tara Williams, Susan Humphreys, Ben Gelbart, Renate Le Marsney, Simon Craig, David Tingay, Arjun Chavan, Andreas Schibler, for the Kids THRIVE Investigators, Paediatric Research in Emergency Departments International Collaborative (PREDICT) and the Australia, New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG). Kids THRIVE Investigators: Shane George ... Subodh Ganu et al

Coupled numerical modelling of progressive failure in creeping constrained landslides under steady state and transient state conditions

ABSTRACT Creeping landslides are a threat to many mountainous communities. Some of these landslides are constraint either artificially or naturally and are slowing down. This slowing down might cause a false impression of safety even though a subsequent reacceleration of the landslide cannot be ruled out. Herein a numerical method is presented that can capture several features that have been observed in the creeping Brattas landslide which affects the ski resort town of St. Moritz. Extensive field observations and laboratory testing have revealed a variety of coupled phenomena, which are also common to other constrained landslides. A simple finite difference algorithm combined with a mechanical constitutive model is presented to simulate these phenomena along the entire slope. The model is based on the mechanism of progressive failure in a zone of intense shearing along the slip surface. Also the effect of rate dependent shear resistance is captured and two different rate dependency relations are analysed. Combining this mechanism with visco-elastic behaviour in the landslide body explains a phase of gradual slowing down of the landslide until 1991. Subsequent acceleration of the landslide can be described by visco-plastic yielding in a zone at the landslide foot where the pressure is close to passive earth pressure. Observed large differences in the velocity of the landslide between its upper and lower sections are attributed to secondary compression. The coupled numerical procedure is also capable of capturing not only the steady state behaviour but also the slope's reaction to precipitation (i.e. the transient state) by introducing a simple linear reservoir type model to relate changes in pore pressure to observed precipitation. The numerical procedure can be used for back-calculating parameters of the slope as well as for predictive purposes. These predictions indicate that further significant deformations in the constructed zone of the landslide have to be expected which makes additional observations and monitoring of sensitive structures essential. In combination with probabilistic models for exposures (e.g. development of precipitation and duration cold periods) the numerical model will also allow for proper risk analysis in the area affected by the Brattas landslide

Misbehavior Scenarios in Cognitive Radio Networks

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JAK2 V617F allele burden quantified by real time quantitative polymerase chain reaction and competitive polymerase chain reaction in patients with chronic myeloproliferative neoplasia

Assessing the clinical significance of JAK2 V617F mutant allele burden is complicated by a myriad of techniques reported to detect and quantify the mutation. As a consequence, the level of sensitivity and how the data is reported vary. Harmonization of well-defined molecular studies would permit evaluation of the clinical significance of measuring allele burden and rapid determination of the efficacy of novel agents for the treatment of chronic myeloproliferative neoplasia via multicenter clinical trials, at the subclinical level. Here we report a comparison between the widely available TaqMan quantitative real time polymerase chain reaction (Q-PCR) and competitive PCR (C-PCR) assays. We found that the tumor load was invariably greater when measured by C-PCR compared to that recorded by Q-PCR. Furthermore, none of the samples converted from undetectable to detectable when the enriched granulocyte (GR) fraction was tested. While a difference in the V617F allele levels was detected between GR fraction and whole blood, this was not statistically significant