Chronic Obstructive Pulmonary DiseaseASI1NCT02248064
Auto-titrating Oxygen in Chronic Respiratory Failure
A study testing Auto-titrating oxygen system in people with Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home, from time to time patients still have low oxygen levels especially when walking which can be harmful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Auto-titrating oxygen system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD and on LTOT
- IPF on LTOT or ambulatory oxgen
Who cannot join
- Unable to mobilise for a 6 minute walk test
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Trust
London, SW3 6NP
About this study
Official title: The Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)
Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home, from time to time patients still have low oxygen levels especially when walking which can be harmful.
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.
Read the detailed description
For patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), disease progression leads to hypoxic respiratory failure necessitating the use of long-term oxygen therapy (LTOT). However a number of studies have shown that despite being on LTOT at home many patients with COPD still experience episodes of intermittent hypoxia (reduction in oxygen saturation <90%). These episodes occur during rest, sleep, talking, walking and sleep. These episodes of intermittent hypoxia can be harmful as they can lead to the development of ischaemic heart disease, induce pulmonary hypertension and affect brain function.
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
- Being tested
- Auto-titrating oxygen system
- Keywords
- Chronic obstructive pulmonary disease, Long term oxygen therapy, Auto-titrating oxygen system, Intelligent oxygen therapy, Idiopathic pulmonary fibrosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-titrating oxygen systemDevice
Also called Intelligent oxygen therapy, iO2t
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed flow oxygen COPD | No intervention | The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm. |
| Auto-titrating arm COPD | Experimental | The 6MWT will done using the auto-titrating oxygen system in this arm of the study Receives: Device: Auto-titrating oxygen system |
| Fixed flow oxygen Pulmonary Fibrosis (IPF) | No intervention | The 6MWT will done using the auto-titrating oxygen system in this arm of the study |
| Auto-titrating arm Pulmonary Fibrosis (IPF) | Experimental | The 6MWT will done using the auto-titrating oxygen system in this arm of the study Receives: Device: Auto-titrating oxygen system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time spent with oxygen saturation below 90%
The participants complete three 6 minute walk tests. There is continuous oxygen saturation monitoring throughout the walk. At the completion of the walk, the percentage of time spent below an oxgen saturation of 90% is calculated
Measured: Assessed at the completion of the 6 minute walk test/s
Secondary outcomes (3)
Total distance walked
Measured: Assessed at the completion of the 6 minute walk test
Mean oxygen saturation
Measured: Assessed during the 6MWT
Total Volume of oxygen delivered
The system records the outflow of oxygen every second. From this data, I can calculate the total volume of oxygen delivered to the patient.
Measured: Assessed at the completion of the 6 minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita K Simonds, MBBS MD FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248064
- Sponsor's protocol ID
- 14IC1995
- Acronym
- ASI1
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2014
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02248064
- Acronym / sponsor ID
- ASI1 / 14IC1995
- Keywords
- Chronic obstructive pulmonary disease, Long term oxygen therapy, Auto-titrating oxygen system, Intelligent oxygen therapy, Idiopathic pulmonary fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home, from time to time patients still have low oxygen levels especially when walking which can be harmful.
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
For patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), disease progression leads to hypoxic respiratory failure necessitating the use of long-term oxygen therapy (LTOT). However a number of studies have shown that despite being on LTOT at home many patients with COPD still experience episodes of intermittent hypoxia (reduction in oxygen saturation <90%). These episodes occur during rest, sleep, talking, walking and sleep. These episodes of intermittent hypoxia can be harmful as they can lead to the development of ischaemic heart disease, induce pulmonary hypertension and affect brain function.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fixed flow oxygen COPD | No intervention | –The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm. |
| Auto-titrating arm COPD | Experimental | Device: Auto-titrating oxygen systemThe 6MWT will done using the auto-titrating oxygen system in this arm of the study |
| Fixed flow oxygen Pulmonary Fibrosis (IPF) | No intervention | –The 6MWT will done using the auto-titrating oxygen system in this arm of the study |
| Auto-titrating arm Pulmonary Fibrosis (IPF) | Experimental | Device: Auto-titrating oxygen systemThe 6MWT will done using the auto-titrating oxygen system in this arm of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD and on LTOT
- IPF on LTOT or ambulatory oxgen
Key exclusion criteria (6 listed)
- Unable to mobilise for a 6 minute walk test
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-titrating oxygen systemAlso: Intelligent oxygen therapy, iO2tThe 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. | Device | Auto-titrating arm COPD, Auto-titrating arm Pulmonary Fibrosis (IPF) |
Primary outcome
The percentage of time spent with oxygen saturation below 90%
Time frame: Assessed at the completion of the 6 minute walk test/s
The participants complete three 6 minute walk tests. There is continuous oxygen saturation monitoring throughout the walk. At the completion of the walk, the percentage of time spent below an oxgen saturation of 90% is calculated
3 secondary outcomes
Total distance walked
Time frame: Assessed at the completion of the 6 minute walk test
Mean oxygen saturation
Time frame: Assessed during the 6MWT
Total Volume of oxygen delivered
Time frame: Assessed at the completion of the 6 minute walk test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Results publicationMoghal, 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.
- This is completed PhD thesis of M Moghal which includes results to this study Autotitrating oxygen in Chronic Respiratory FailureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita K Simonds, MBBS MD FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-titrating oxygen system in people with Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of time spent with oxygen saturation below 90% (time frame: Assessed at the completion of the 6 minute walk test/s). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.