Intelligent Oxygen Therapy During Activities of Daily Living
NCT ID: NCT02683486
Last Updated: 2023-11-29
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
25 participants
INTERVENTIONAL
2016-01-31
2017-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Activities of daily living on iO2t
Patients will complete simulated activities of daily living on intelligent oxygen therapy (an auto-titrating oxygen system)
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.
Activities of daily living on LTOT
Patients will complete activities of daily living on their usual long-term oxygen therapy.
Long-term oxygen therapy
This is the patients usual long-term oxygen therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Long-term oxygen therapy
This is the patients usual long-term oxygen therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Currently on or eligible for LTOT for respiratory failure
Exclusion Criteria
2. Exacerbation of underlying lung disease in the past 4 weeks
3. Inability to understand English
4. Significant co-morbidities
5. Patients who lack capacity to consent
6. Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anita Simonds, FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Brompton and Harefield NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Related Links
Access external resources that provide additional context or updates about the study.
This is link to PhD thesis of M Moghal showing results of study on Intelligent Oxygen therapy during Activities of Daily Living
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15IC2835
Identifier Type: -
Identifier Source: org_study_id