A pilot study to assess whether humidified oxygen is more effective than standard oxygen therapy in treating children with acute severe asthma

Alder Hey Children's Hospital (UK)0 个研究点目标入组 90 人开始时间: 2013年11月21日最近更新: 2018年6月11日

试验速览

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•Patients between 2 and 16 years of age attending A&E with a clinical diagnosis of acute severe or potentially life-threatening asthma according to the BTS/SIGN guidelines and who still require oxygen after initial standard nebuliser therapy.
•For children 6 years and older, severe asthma will be based on the following criteria being met:
•1. Oxygen saturations less than 92% while breathing room air and one of either:
•2. Being too breathless to talk in complete sentences
•3. Heart rate greater than 120/min
•4. Respiratory rate greater than 30/min
•5. Use of accessory neck muscles
•For children aged 2 to 5 years of age, severe asthma will be based on the following criteria being met:
•1. Oxygen saturations less than 92% while breathing room air and one of either:
•2. Being too breathless to talk or eat
•3. Heart rate greater than 130/min
•4. Respiratory rate greater than 50/min
•5. Use of accessory neck muscles

•1. Requiring admission to intensive care at time of recruitment
•2. Previous participation in this iteration of the Humox study
•3. Other significant respiratory disease (chronic lung disease of prematurity, previous significant chest infections)
•4. Any other significant underlying medical problem (immunodeficiency, neurological and cardiac conditions)
•5. Previously or currently involved with a trial of a medicinal product in the three months preceding screening
•6. Parents/guardians who are unable to give informed consent

发起方

Alder Hey Children's Hospital (UK)