Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2014-07-31
2015-11-30
Brief Summary
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The investigators have designed a new system of delivering oxygen to overcome the above problem. The system measures the oxygen saturations of a patient and subsequently adjust the flow of oxygen to meet a pre-set oxygen saturation target.
Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.
Detailed Description
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In order to reduce these episodes of intermittent hypoxia, the investigators have designed an auto-titrating, closed-loop oxygen system which automatically adjust the flow of oxygen to match a given oxygen saturation target. This allows individualisation and optimisation of oxygen therapy for every patient.
Mechanism of action:
A pulse oximeter is attached to the ear or finger of a patient. This send the oxygen saturation reading to a control centre (located in a mobile phone). The control centre is pre-programmed to maintain a set oxygen saturation target. The control centre outputs a signal to a flow meter which regulated the outflow of oxygen.
In this study, the investigators will recruit patients with COPD on LTOT and patients with IPF on LTOT or ambulatory oxygen to undergo three 6 minute walk tests (6MWT). The first will be on air (practice walk), the second will be on their usual ambulatory oxygen and the third on the auto-titrating oxygen system. The order of the second and third walks be randomly selected. The patient will be blinded as to which type of oxygen they will be receiving in the second and third walk.
Hypothesis: the investigators iO2t system is better at preventing and treating oxygen desaturations that occur during a 6MWT than usual fixed flow ambulatory oxygen therapy
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Fixed flow oxygen COPD
The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm.
No interventions assigned to this group
Auto-titrating arm COPD
The 6MWT will done using the auto-titrating oxygen system in this arm of the study
Auto-titrating oxygen system
The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.
Fixed flow oxygen Pulmonary Fibrosis (IPF)
The 6MWT will done using the auto-titrating oxygen system in this arm of the study
No interventions assigned to this group
Auto-titrating arm Pulmonary Fibrosis (IPF)
The 6MWT will done using the auto-titrating oxygen system in this arm of the study
Auto-titrating oxygen system
The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.
Interventions
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Auto-titrating oxygen system
The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IPF on LTOT or ambulatory oxgen
Exclusion Criteria
* Unable to consent to study,
* Partial pressure of oxygen \< 6.0 kilopascals (kPa) or Partial pressure of carbon dioxide \> 8kilopascals on air,
* Exacerbation of the underlying lung disease in the previous 4 weeks
* Unstable cardiovascular disease (e.g. arrhythmia, hypertension/hypotension or angina)
* Pregnancy
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Anita K Simonds, MBBS MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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Royal Brompton and Harefield NHS Trust
London, , United Kingdom
Countries
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References
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Moghal, M, Goburdhun, R, Hopkinson, N, Man, W, Morrell, M, Dickinson, R et al. An auto-titrating intelligent oxygen therapy (iO 2 T) system in COPD patients: A randomised cross-over trial. European Respiratory Journal. (2015). 46. OA3281. 10.1183/13993003.congress-2015.OA3281.
Related Links
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This is completed PhD thesis of M Moghal which includes results to this study Autotitrating oxygen in Chronic Respiratory Failure
Other Identifiers
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14IC1995
Identifier Type: -
Identifier Source: org_study_id