Comfort comparison of two bi-level devices in patients with chronic respiratory diseases.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
The comfort of a device in treating respiratory failure is critical to ensure compliance and effective treatment times. The ideal ventilatory support device in respiratory failure may be one that can deliver both Non-Invasive Ventilation (NIV) and Nasal High Flow (NHF) therapy and be easily switched between the 2 modes, depending on the clinical scenario and patient preference. This study was a preliminary investigation of an NHF device that is also capable of using the internal flow generator to provide NIV through bi-level pressure support. This dual NHF/NIV device can easily switch between the two therapy modes - possibly the ideal application for NHF therapy, making it a practical application for hospital ward-based therapy. We compared the NIV function of this NHF/NIV device against a standard Resmed NIV device. Comfort scores showed no significant difference between the standard Resmed NIV device and NHF/NIV device in this randomised controlled cross-over study in patients with chronic respiratory diseases at risk of hypercapnic respiratory failure. The NHF/NIV device has been shown to trigger satisfactorily and produced similar clinical effects to the Resmed device while overall more patients preferred its use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients diagnosed with chronic respiratory diseases associated with chronic respiratory failure
排除标准
- •Significant hypoxia
- •oStO2 < 88 % after 20-30 minutes of Sentec stabilisation or for a sustained period during the intervention (according to investigators clinical discretion)
- •Chronic respiratory disease that is not deemed to be stable
- •oCurrent exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 1 week
- •oHospital admission for an acute exacerbation in the last 2 weeks
- •Recent cardiac or respiratory arrest
- •Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
- •Coma, decreased level of consciousness or agitation
- •Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
- •Cerebrospinal fluid leak, abnormalities of the cribriform plate or prior history of head trauma.
- •Use of supplemental oxygen
- •Fluid depletion, poor left ventricular function or cardiac disease without adequate pharmacological therapy
- •Pneumothorax, or at high clinical risk of pneumothorax or barotrauma due to, for example, previous pneumothorax, pneumomediastinum, severe bullous lung disease, acute lung injury secondary to pneumonia, interstitial lung diseases, cystic fibrosis and neuromuscular disease
- •Diagnosis of a notifiable disease
- •Use of an implantable medical device
- •Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results