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

Evaluating Customer Requirements in Eco-VA

Products must be environmentally friendly as well as conform with the market in order to go for a sustainable society. A tool named Eco-Value Analysis (Eco-VA) has been developed by modifying the traditional Value Analysis (VA). Eco-VA allows product developers to analyze functions of a product from economic costs, customers? importance, and environmental impacts. However, Eco-VA has the following possible improvements due to the characteristics of VA. First, it is sometimes difficult to obtain correct and accurate requirements of end users. There can be a way for end users to do it in more ?user-oriented? way. Second, Eco-VA does not support product developers with finding the product concept to be investigated. In order to improve in these points, this paper presents a new method. First, the modelling method of Service Engineering (SE) is adopted. A function to represent value is replaced with a Receiver?s State Parameter (RSP), which designers represent the benefits or costs in SE. Second, Conjoint Analysis and AHP are applied to end users? evaluation. Conjoint Analysis is carried out using design solution candidates represented with a limited small number of attributes and their levels. The presented method is verified by its application to a food processing machine