Automated Oxygen Titration With O2matic During Walking in Patients With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Perceived dyspnea intensity using Borg CR10 dyspnea scale
Study Overview
Brief Summary
Purpose: to evaluate the immediate effect of automated oxygen titration compared to usual fixed-dose oxygen treatment during exercise in patients with COPD on long-term oxygen treatment.
Methods: The study will be conducted as a double blinded randomized crossover trial with two arms. 40 ambulatory patients with COPD and home oxygen treatment will be included from AHH Hospital's catchment area. The patients will conduct two Endurance Shuttle Walk Tests (ESWT) in a crossover design using an O2matic device to deliver a variable oxygen dosage set at an SpO2-target of 90-94% and an O2-flow of 0 - 15 liters/min and using the patients´ usual fixed-dose oxygen delivery, in a randomized order. In both arms O2matic will monitor pulse rate and SpO2 continuously during the test, but only in the automated oxygen titration arm will O2matic adjust oxygen flow. The patient and the physiotherapist supervising the tests will be blinded to the oxygen dose. Primary outcome is the changes in perceived dyspnea intensity using Borg CR10 scale between walking with automated titration compared to fixed-dose treatment. Secondary outcomes are differences in walking time, the average oxygen consumption between automated oxygen titration and fixed-dose treatment and difference in time spent within acceptable SpO2-interval.
Detailed Description
Long-term oxygen treatment (LTOT) at home is essential for patients with COPD and chronic hypoxemia. It is recommended that the given oxygen flow rate should be enough to keep the blood saturation (SpO2) between 90% and 94%. Although the oxygen need increases with activity, there is no consensus on oxygen dosage during activity (BTS-guideline).
The purpose of this study is to evaluate the immediate effect of automated oxygen titration (AOT) compared to usual fixed-dose oxygen treatment (FOT) during exercise in patients with COPD on long-term oxygen treatment.
Method The study will be performed on 40 patients with COPD and on LTOT. An incremental shuttle walk test (ISWT) will be performed to establish the walking speed corresponding to 75% of the estimated peak oxygen consumption. The patients will all use a rollator as walking aid and the oxygen equipment will be placed in the rollator. The patients will after inclusion conduct two Endurance Shuttle Walk Tests (ESWT) with FOT and AOT respectively in a randomized order. One ESWT will be performed using O2matic to deliver a variable oxygen dosage set at an SpO2-target of 90 to 94 % and a O2-flow of 0 - 15 liters/min (AOT). The other ESWT will be performed using the usual fixed-dose oxygen delivery (FOT).
The patients will also conduct two six minutes walking tests (6 MWT) with FOT and AOT in random order in the same way as mentioned above.
Assessments:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patient will be blinded for the oxygen supply. An independent person will prepare the oxygen setup with O2matic in manual mode for fixed dose oxygen and in automatic mode for automated oxygen titration. The assessor conducting the walking test is blinded.
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Verified history of COPD with FEV1/FVC < 0,70
- •Hypoxemic at rest (SpO2 ≤ 90 %) and fulfilment of criteria for LTOT
- •Able to walk at least 70 meters
- •Cognitively able to participate in the study and willing to give informed consent
Exclusion Criteria
- •Pulmonary or cardiac condition other than COPD limiting exercise performance
- •Unstable heart condition or stenotic aortic valve disease
- •A physical condition including paralysis, lower extremity pain, or back problem limiting exercise performance
- •Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
Arms & Interventions
Fixed dose oxygen
O2Matic deliver the usual fixed-dose oxygen treatment during walking.
Intervention: Fixed-dose compared to variable oxygen flow supplementation during walking (Other)
Automated oxygen titration
O2Matic deliver a variable oxygen dosage set at an SpO2-target of 90 to 94 % and a O2-flow of 0 - 15 liters/min during walking.
Intervention: Fixed-dose compared to variable oxygen flow supplementation during walking (Other)
Outcomes
Primary Outcomes
Perceived dyspnea intensity using Borg CR10 dyspnea scale
Time Frame: Twenty minutes
Difference in Dyspnea Borg CR10 (from 0-10) scores in the ESWT at isotimes (every minute) in both tests walking with automated titration compared to fixed-dose treatment. The Borg scale starts at number 0 where your breathing is causing the patient no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal
Secondary Outcomes
- Walking time(Twenty minutes)
- Walking distance in meters(six minutes)
- Time with Hypoxemia(Twenty minutes)
- Average numbers of liter oxygen per minutes(Twenty minutes)
Investigators
Linette Marie Kofod
Physiotherapist
Hvidovre University Hospital