The effect of mechanical insufflation-exsufflation and inspiratory muscle training on clinical outcomes and health-related quality of life in paediatric and adolescent patients with neuromuscular diseases presenting with respiratory muscle weakness: a multi-centre trial.

Anri Human0 个研究点目标入组 88 人开始时间: 2015年6月10日最近更新: 2023年5月29日

试验速览

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•MI-E study:
•Documented diagnosis of any congenital or paediatric/adolescent NMD.
•Patients admitted for acute respiratory infections and/or respiratory complications such as increased work of breathing, respiratory muscle fatigue, orthopnoea, retention of secretions/inability to clear secretions, decreased peak expiratory cough flow.
•Documented diagnosis of any congenital or paediatric/adolescent NMD.
•Patients admitted for acute respiratory infections and/or respiratory complications such as increased work of breathing, respiratory muscle fatigue, orthopnoea, retention of secretions/inability to clear secretions, decreased peak expiratory cough flow.

•MI-E study:
•Unstable vital signs such as resting arterial O2 saturation (SpO2) of <90% and/or end-tidal carbon dioxide tension (PETCO2) of >7kPa on the day of recruitment. If the vital signs should stabilise within the following 48 hours, patients will be reconsidered for inclusion.
•If patients are terminally ill, have bullae emphysema, scoliosis > 100 degrees (La Place¿s Law) or cannot cooperate/follow basic instructions.
•Previous history of a pneumothorax/ pneumo-mediastinum, recent (< 6months) barotrauma, thoracic/abdominal surgery.
•Patient that present with cardiac failure (confirmed by a physician).
•Patient that are participating in the IMT study, as this might influence their reaction to MI-E treatment as well as their clinical outcomes.
•Patients that are unable to cooperate/comply with the cough assist technique(s).
•Patients that are terminally ill.
•Patients with <25% predicted value VC will be excluded.
•Patients that are unable to cooperate/comply with the training programme.

发起方

Anri Human