ACTRN12623000835640尚未招募Unknown
A Phase II Randomised Crossover Trial to Assess Feasibility of Domiciliary Nasal High Flow for Chronic Breathlessness in People with Interstitial Lung Disease
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •oAge 18 years and over
- •oconfirmed ILD as determined by:
- •oradiological evidence on CT chest scan (within last 5 years) or
- •opulmonary function tests with DLco less than 60% and/or restrictive spirometry (within last 3 years)
- •ophysician confirmed optimisation of treatment of ILD
- •obreathlessness as determined by modified medical research council dyspnea score (mMRC) greater than on equal to 2
- •onot currently on home, long-term, oxygen therapy for greater than or equal to 16h/day and not meeting criteria for home long-term oxygen therapy (i.e., SpO2 at rest greater than or equal to 92%)
- •opatients using only portable oxygen therapy on exertion remain eligible
- •oable to provide written informed consent
- •ocapable of completing assessments and following the study procedures.
排除标准
- •oAcute exacerbation of ILD, including but not limited to:
- •ochest infection in the past 4 weeks (unstable)
- •oon home long-term oxygen therapy for greater than or equal to 16h/day
- •oenrolled in other clinical trials which may impact breathlessness (as determined by the study investigator)
- •ocommenced (or required to commence during the trial) new treatment for ILD, including but not limited to, anti-fibrotic, opioids or benzodiazepines in the last 14 days
- •oprevious adverse reaction to NHF
- •oclinician predicted survival less than or equal to 3 months
- •opregnant or breast feeding
- •ocurrent alcoholism or drug abuse
- •ountreated pneumothorax
- •ocontradictions to NHF use, including
- •orequires home long-term oxygen therapy or non-invasive ventilation
- •oaltered conscious state
- •osuspected or known base of skull fracture
- •oinability to maintain own airway or tolerate nasal prongs
- •orecent (last 30 days) nose or upper airway surgery – including transsphenoidal approach
- •osignificant facial fractures or trauma (last 30 days)
- •onasal obstruction or packing
研究者
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