INFINITE: A Phase II Randomised Crossover Trial to Assess Feasibility of Domiciliary Nasal High Flow for Chronic Breathlessness in People with Interstitial Lung Disease
- Conditions
- interstitial lung diseaseRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12623000835640
- Lead Sponsor
- Alfred Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method