A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations

Hospital Clinic of Barcelona0 个研究点目标入组 52 人开始时间: 2003年6月最近更新: 2008年6月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Hospital Clinic of Barcelona
入组人数: 52
主要终点: Change in PaCO2 from baseline

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age between 18 and 75
•Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):
•PaCO2 > 45 mmHg
•Night time oxygen saturation < 88% at least for 5 consecutive minutes
•In neuromuscular diseases, PIM < 60 cmH2O or FVC < 50% of theoretical.
•Stable disease.
•Airway access through nasal mask.
•Ability to provide written informed consent.
•Ability to attend the visits

排除标准

•Contraindications for mechanical ventilation:
•Patient with terminal disease or vegetative state
•Lack of motivation of the patient
•Lack of family or social support
•Patients clinically unstable
•Agitation or lack of co-operation
•Depression.
•Patients with acute symptoms requiring hospital admission.
•Need for airway access through tracheostomy, face mask or mouth piece.
•Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
•Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
•Lack of understanding of the study procedures.

结局指标

主要结局

Change in PaCO2 from baseline

时间窗: 6 months

次要结局

Change in PaCO2 from start of mechanical ventilation
Adaptation failure
6-minute walking test

研究者

发起方

Hospital Clinic of Barcelona

申办方类型

Other

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