Auto-titrating Oxygen in Chronic Respiratory Failure (ASI1)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Device: Auto-titrating oxygen system

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton and Harefield NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fixed flow oxygen COPD; The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm.
Experimental: Auto-titrating arm COPD; The 6MWT will done using the auto-titrating oxygen system in this arm of the study	Device: Auto-titrating oxygen system; 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
No Intervention: Fixed flow oxygen Pulmonary Fibrosis (IPF); The 6MWT will done using the auto-titrating oxygen system in this arm of the study
Experimental: Auto-titrating arm Pulmonary Fibrosis (IPF); The 6MWT will done using the auto-titrating oxygen system in this arm of the study	Device: Auto-titrating oxygen system; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at the completion of the 6 minute walk test/s

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total distance walked		Assessed at the completion of the 6 minute walk test
Mean oxygen saturation		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.	Assessed at the completion of the 6 minute walk test

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Anita K Simonds, MBBS MD FRCP, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

General 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.

Helpful Links

• This is completed PhD thesis of M Moghal which includes results to this study Autotitrating oxygen in Chronic Respiratory Failure

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimated): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Idiopathic pulmonary fibrosis; Auto-titrating oxygen system; Long term oxygen therapy; Intelligent oxygen therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Interstitial; Chronic Disease; Fibrosis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 14IC1995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO