Intelligent Oxygen Therapy During Activities of Daily Living

NCT02683486 | Completed

• 1 other identifier: 15IC2835
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia; COPD; Hyperoxia

Outcome Measures

Primary Outcomes (1)

• The percentage of time spent with SpO2 <90% during the activities of daily living - 55 minutes

  Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)

Secondary Outcomes (4)

• Mean SpO2 during the activities of daily living - 55 minutes

  Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)

• Mean Heart rate during the activities of daily living - 55 minutes

  Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)

• Borg score for breathlessness and fatigue at the end of activities of daily living (55 minutes)

  At the end of activities of daily living (55 minutes)

• Total volume of oxygen delivered during simulated activities of daily living during the activities of daily living (55 minutes)

  Calculated over the duration of the time the patient is carrying out activities of daily living (55 minutes)

Study Arms (2)

Activities of daily living on iO2t

EXPERIMENTAL

Patients will complete simulated activities of daily living on intelligent oxygen therapy (an auto-titrating oxygen system)

Device: Intelligent oxygen therapy (an auto-titrating oxygen system)

Activities of daily living on LTOT

ACTIVE COMPARATOR

Patients will complete activities of daily living on their usual long-term oxygen therapy.

Device: Long-term oxygen therapy

Interventions

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.

Activities of daily living on iO2t

Long-term oxygen therapy DEVICE

This is the patients usual long-term oxygen therapy

Activities of daily living on LTOT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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

  RESULT

Related Links

• This is link to PhD thesis of M Moghal showing results of study on Intelligent Oxygen therapy during Activities of Daily Living

MeSH Terms

Conditions

Hypoxia; Pulmonary Disease, Chronic Obstructive; Hyperoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Anita Simonds, FRCP

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 17, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 15, 2017
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)