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NCT Number: NCT02683486

Intelligent 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Currently on or eligible for LTOT for respiratory failure

Exclusion criteria

  • 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

Treatment and study plan

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 therapy

Device

This is the patients usual long-term oxygen therapy

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients on Long-term Oxygen Therapy During Activities of Daily Living

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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