None listed
Conditions
Brief summary
Existing small portable oxygen concentrators use pulsed delivery that claim some equivalency to continuous flow. This is an area of study that has little to no clinical validation and continuous flow (primarily from cylinders and large home stationary concentrators) is considered the gold standard by the medical community. This pilot study will evaluate oxygen saturation and six-minute walk distance in patients requiring ambulatory oxygen. Two six-minute walk tests will be performed with the subjects using both the battery powered Juno delivering continuous oxygen flow and the continuous flow oxygen cylinder in randomized order. The study aims to establish non-inferiority between the new battery powered device and the current oxygen cylinder gold standard. A non-inferiority margin of 7% will be evaluated, as this was the mean difference in repeat 6 minute walk tests in a large cohort study. (Hernandes 2012) This study will inform future product development and a larger follow up study as a genuine, renewable alternative to oxygen cylinders.
Interventions
Functional status and physiological parameters will be recorded in patients receiving a supplemental oxygen therapy trial from both the Juno portable oxygen concentrator and oxygen cylinder in a randomized, cross over interventional study. Measurements will be recorded by a small electronic data capture device fitted to an elastic strap placed around the chest. This will measure respiratory effort as chest movement with additional measurements of air flow recorded via a nasal cannula and oxygen
Functional status and physiological parameters will be recorded in patients receiving a supplemental oxygen therapy trial from both the Juno portable oxygen concentrator and oxygen cylinder in a randomized, cross over interventional study. Measurements will be recorded by a small electronic data capture device fitted to an elastic strap placed around the chest. This will measure respiratory effort as chest movement with additional measurements of air flow recorded via a nasal cannula and oxygen saturation via a finger probe oximeter, both connected to the chest mounted device. Oxygen delivery is not individualised or titrated to maintain a target saturation, patients will receive a fixed rate of 2L/min of continuous flow oxygen delivered from both the cylinder (approximately 99% purity) and Juno portable oxygen concentrator (approximately 91% purity) for around 16 minutes each, in randomized order. Oxygen will only be delivered for 5 minutes prior to, during the 6 minute walk test and 5 minutes after, for the purposes of assessing the effect of supplemental oxygen on oxygen saturation and walk distance. Oxygen will not be provided beyond the study period unless the patient meets oxygen prescription requirements as usual care, in which case their physician will discuss oxygen cylinder or battery powered concentrator options. Juno is not yet commercially available. Two 6 minute walk tests will be conducted as a flat walk in an open corridor at the patient's own pace. The two walk tests will be conducted 1 hour apart (or longer if requested) to allow a rest period. The entire trial will take place under direct observation and will be completed in around 2 hours in total (usually completed on the same day)
Sponsors
Roam Technologies Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age and over Resting oxygen saturation 92% or less Medically suitable for 6 minute walk tests
Exclusion criteria
Resting oxygen saturation above 92% Inability to safely complete 6MWT
Outcome results
None listed