Auto-titrating Oxygen in Chronic Respiratory Failure

NCT02248064 | Completed

• 1 other identifier: 14IC1995
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis

Keywords

Chronic obstructive pulmonary disease; Long term oxygen therapy; Auto-titrating oxygen system; Intelligent oxygen therapy; Idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Assessed at the completion of the 6 minute walk test

Study Arms (4)

Fixed flow oxygen COPD

NO INTERVENTION

The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm.

Auto-titrating arm COPD

EXPERIMENTAL

The 6MWT will done using the auto-titrating oxygen system in this arm of the study

Device: Auto-titrating oxygen system

Fixed flow oxygen Pulmonary Fibrosis (IPF)

NO INTERVENTION

The 6MWT will done using the auto-titrating oxygen system in this arm of the study

Auto-titrating arm Pulmonary Fibrosis (IPF)

EXPERIMENTAL

The 6MWT will done using the auto-titrating oxygen system in this arm of the study

Device: Auto-titrating oxygen system

Interventions

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.

Also known as: Intelligent oxygen therapy, iO2t

Auto-titrating arm COPD; Auto-titrating arm Pulmonary Fibrosis (IPF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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.

  RESULT

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Officials

• Anita K Simonds, MBBS MD FRCP

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 25, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)