HypoxiaNCT02683486
Intelligent Oxygen Therapy During Activities of Daily Living
A study testing Intelligent oxygen therapy (an auto-titrating oxygen system) and Long-term oxygen therapy in people with Hypoxia and COPD, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether an auto-titrating oxygen system can maintain constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT) during activities of daily living. Currently LTOT is provided at a constant fixed-flow rate e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intelligent oxygen therapy (an auto-titrating oxygen system) and Long-term oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 15 Jan 2017
- 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
- Age >18 years
- Currently on or eligible for LTOT for respiratory failure
Who cannot join
- LTOT flow rate ≥4 litres per minute
- Exacerbation of underlying lung disease in the past 4 weeks
- Inability to understand English
- Significant co-morbidities
- Patients who lack capacity to consent
- 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 on Long-term Oxygen Therapy During Activities of Daily Living
The aim of this study is to assess whether an auto-titrating oxygen system can maintain constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT) during activities of daily living.
Currently LTOT is provided at a constant fixed-flow rate e.g. 2 litres per minute all the time after appropriate assessment. The flow rate is not changed during usual household activities but is increased for walking. A number of studies have investigated the SpO2 of patients on LTOT during the daytime in patients' homes. The results have shown that patients' SpO2 decreases intermittently whilst they are doing activities of daily living such as watching television, putting away the shopping, having a shower or bath and dressing and undressing. This is a problem as it can lead to breathlessness, increased stress on the heart and affect brain function. In order to correct the drop in SpO2 that patients experience during everyday activities, the investigators have developed an oxygen system, which can automatically change the amount of oxygen delivered depending on a patients' oxygen saturations - an auto-titrating oxygen system. In this study, patients on LTOT will be asked to simulate a series of activities of daily living twice: once whilst on their usual fixed-flow oxygen therapy and once on the auto-titrating oxygen system. The activities will be carried out in a hospital setting. During the activities, SpO2 will be recorded continuously. The main outcome of interest from the study will be the SpO2 throughout the study on fixed-flow oxygen and the auto-titrating oxygen system.
Read the detailed description
Long-term oxygen therapy (LTOT) is prescribed for patients with stable severe hypoxemic respiratory failure according to specific criteria set out in different guidelines from international respiratory societies. The aim of LTOT is to maintain the resting partial pressure of oxygen (PO2) >60 mmHg or oxygen saturation (SpO2) >90%.
A number of studies have demonstrated that whilst at home, patients on LTOT experience episodes of intermittent hypoxia (SpO2 <90%) and spend significant amounts of time with SpO2 <90%. These episodes of desaturation occur most frequently during activities of daily living and may be harmful as they could lead to pulmonary hypertension, arrhythmias and ischaemic heart disease. Simply increasing the LTOT flow rate by 1 or 2 litres in one option but this exposed the patients to hyperoxaemia and the risk of hypercapnia. An another method optimising LTOT is to utilise an auto-titrating oxygen system. These system allow close control of SpO2 by automatically adjusting the flow of oxygen to match a target SpO2. At the Royal Brompton Hospital and Imperial College London, the investigators have developed our own auto-titrating oxygen system - called intelligent oxygen therapy (iO2t).
This system has been tested in patients with chronic obstructive pulmonary disease (COPD) and LTOT during a 6 minute walk test with promising results (ERS 2015).
The aim of this study is to investigate whether the intelligent oxygen therapy system can reduce intermittent hypoxia in patients on LTOT during simulated activities of daily living. Patients will be asked to a series of activities of daily living over a period of 1 hour including: washing, dressing, putting away shopping and cleaning. The patients will do these activities twice: once on their usual LTOT and once on the auto-titrating oxygen system in a cross-over design.
- Being tested
- Intelligent oxygen therapy (an auto-titrating oxygen system), Long-term oxygen therapy
- Medical subject headings
- Hypoxia, Pulmonary Disease, Chronic Obstructive, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent oxygen therapy (an auto-titrating oxygen system)Device
This device is an auto-titrating oxygen system. The system is programmed to maintain a specific target SpO2 by automatically adjusting the oxygen flow rate. The system can deliver flow rates of 0-5 litres/minute.
Long-term oxygen therapyDevice
This is the patients usual long-term oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Activities of daily living on iO2t | Experimental | Patients will complete simulated activities of daily living on intelligent oxygen therapy (an auto-titrating oxygen system) Receives: Device: Intelligent oxygen therapy (an auto-titrating oxygen system) |
| Activities of daily living on LTOT | Active comparator | Patients will complete activities of daily living on their usual long-term oxygen therapy. Receives: Device: Long-term oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time spent with SpO2 <90% during the activities of daily living - 55 minutes
Measured: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Secondary outcomes (4)
Mean SpO2 during the activities of daily living - 55 minutes
Measured: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Mean Heart rate during the activities of daily living - 55 minutes
Measured: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Borg score for breathlessness and fatigue at the end of activities of daily living (55 minutes)
Measured: At the end of activities of daily living (55 minutes)
Total volume of oxygen delivered during simulated activities of daily living during the activities of daily living (55 minutes)
Measured: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion1 Jan 2017
- Study completion15 Jan 2017
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 HypoxiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anita Simonds, FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683486
- Sponsor's protocol ID
- 15IC2835
- Status last verified
- Nov 2023
- First submitted
- 26 Jan 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mohammad Moghal, Rishi Goburdhun, Mary Morrell, Robert Dickinson, Anita Simonds A Novel Smartphone Based Auto-Titrating Oxygen System Reduces Intermittent Hypoxia During Activities of Daily Living in Patients on Long-Term Oxygen Therapy. American Journal of Respiratory and Critical Care Medicine 2017;195:A7709
Study at a glance
From the registry record, last updated by the sponsor on 29 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 on Long-term Oxygen Therapy During Activities of Daily Living
- ClinicalTrials.gov ID
- NCT02683486
- Acronym / sponsor ID
- 15IC2835
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 17 Feb 2016 (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.
The aim of this study is to assess whether an auto-titrating oxygen system can maintain constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT) during activities of daily living.
Currently LTOT is provided at a constant fixed-flow rate e.g. 2 litres per minute all the time after appropriate assessment. The flow rate is not changed during usual household activities but is increased for walking. A number of studies have investigated the SpO2 of patients on LTOT during the daytime in patients' homes. The results have shown that patients' SpO2 decreases intermittently whilst they are doing activities of daily living such as watching television, putting away the shopping, having a shower or bath and dressing and undressing. This is a problem as it can lead to breathlessness, increased stress on the heart and affect brain function. In order to correct the drop in SpO2 that patients experience during everyday activities, the investigators have developed an oxygen system, which can automatically change the amount of oxygen delivered depending on a patients' oxygen saturations - an auto-titrating oxygen system. In this study, patients on LTOT will be asked to simulate a series of activities of daily living twice: once whilst on their usual fixed-flow oxygen therapy and once on the auto-titrating oxygen system. The activities will be carried out in a hospital setting. During the activities, SpO2 will be recorded continuously. The main outcome of interest from the study will be the SpO2 throughout the study on fixed-flow oxygen and the auto-titrating oxygen system.
Detailed description
Long-term oxygen therapy (LTOT) is prescribed for patients with stable severe hypoxemic respiratory failure according to specific criteria set out in different guidelines from international respiratory societies. The aim of LTOT is to maintain the resting partial pressure of oxygen (PO2) >60 mmHg or oxygen saturation (SpO2) >90%.
A number of studies have demonstrated that whilst at home, patients on LTOT experience episodes of intermittent hypoxia (SpO2 <90%) and spend significant amounts of time with SpO2 <90%. These episodes of desaturation occur most frequently during activities of daily living and may be harmful as they could lead to pulmonary hypertension, arrhythmias and ischaemic heart disease. Simply increasing the LTOT flow rate by 1 or 2 litres in one option but this exposed the patients to hyperoxaemia and the risk of hypercapnia. An another method optimising LTOT is to utilise an auto-titrating oxygen system. These system allow close control of SpO2 by automatically adjusting the flow of oxygen to match a target SpO2. At the Royal Brompton Hospital and Imperial College London, the investigators have developed our own auto-titrating oxygen system - called intelligent oxygen therapy (iO2t).
This system has been tested in patients with chronic obstructive pulmonary disease (COPD) and LTOT during a 6 minute walk test with promising results (ERS 2015).
The aim of this study is to investigate whether the intelligent oxygen therapy system can reduce intermittent hypoxia in patients on LTOT during simulated activities of daily living. Patients will be asked to a series of activities of daily living over a period of 1 hour including: washing, dressing, putting away shopping and cleaning. The patients will do these activities twice: once on their usual LTOT and once on the auto-titrating oxygen system in a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activities of daily living on iO2t | Experimental | Device: Intelligent oxygen therapy (an auto-titrating oxygen system)Patients will complete simulated activities of daily living on intelligent oxygen therapy (an auto-titrating oxygen system) |
| Activities of daily living on LTOT | Active comparator | Device: Long-term oxygen therapyPatients will complete activities of daily living on their usual long-term oxygen therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Currently on or eligible for LTOT for respiratory failure
Key exclusion criteria (6 listed)
- LTOT flow rate ≥4 litres per minute
- Exacerbation of underlying lung disease in the past 4 weeks
- Inability to understand English
- Significant co-morbidities
- Patients who lack capacity to consent
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 |
|---|---|---|
| Intelligent oxygen therapy (an auto-titrating oxygen system)This device is an auto-titrating oxygen system. The system is programmed to maintain a specific target SpO2 by automatically adjusting the oxygen flow rate. The system can deliver flow rates of 0-5 litres/minute. | Device | Activities of daily living on iO2t |
| Long-term oxygen therapyThis is the patients usual long-term oxygen therapy | Device | Activities of daily living on LTOT |
Primary outcome
The percentage of time spent with SpO2 <90% during the activities of daily living - 55 minutes
Time frame: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
4 secondary outcomes
Mean SpO2 during the activities of daily living - 55 minutes
Time frame: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Mean Heart rate during the activities of daily living - 55 minutes
Time frame: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
Borg score for breathlessness and fatigue at the end of activities of daily living (55 minutes)
Time frame: At the end of activities of daily living (55 minutes)
Total volume of oxygen delivered during simulated activities of daily living during the activities of daily living (55 minutes)
Time frame: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)
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 29 Nov 2023.
- Results publicationMohammad Moghal, Rishi Goburdhun, Mary Morrell, Robert Dickinson, Anita Simonds A Novel Smartphone Based Auto-Titrating Oxygen System Reduces Intermittent Hypoxia During Activities of Daily Living in Patients on Long-Term Oxygen Therapy. American Journal of Respiratory and Critical Care Medicine 2017;195:A7709
- This is link to PhD thesis of M Moghal showing results of study on Intelligent Oxygen therapy during Activities of Daily LivingLink 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 Simonds, 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 Intelligent oxygen therapy (an auto-titrating oxygen system) and Long-term oxygen therapy in people with Hypoxia and COPD, 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 29 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 SpO2 <90% during the activities of daily living - 55 minutes (time frame: Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)). 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 NCT02683486, 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 29 Nov 2023.