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NCT Number: NCT02248064

Auto-titrating Oxygen in Chronic Respiratory Failure

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.

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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

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • COPD and on LTOT
  • IPF on LTOT or ambulatory oxgen

Exclusion criteria

  • 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

Treatment and study plan

Auto-titrating oxygen system

Device

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 names: Intelligent oxygen therapy, iO2t

Primary outcomes

  1. 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

Secondary outcomes

  1. Total distance walked

    Time frame: Assessed at the completion of the 6 minute walk test

  2. Mean oxygen saturation

    Time frame: Assessed during the 6MWT

  3. Total Volume of oxygen delivered

    Time frame: Assessed at the completion of the 6 minute walk test

    The system records the outflow of oxygen every second. From this data, I can calculate the total volume of oxygen delivered to the patient.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

The Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)

Acronym: ASI1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Nov 28, 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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