Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance
Study Details
Study Description
Brief Summary
The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: automated nasal oxygen titration with FreeO2 alone The participant received automated nasal oxygen titration administered by a closed loop system (FreeO2) during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). The objective of this system is maintain SpO2 a the pre-specified target level (94% in this study) with an automatic adjustment of oxygen flow second by second. |
Device: Automated nasal O2 titration with FreeO2
The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT)
Other Names:
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| Active Comparator: automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy In addition to nasal oxygen titration administered by a closed loop system (FreeO2), the participant received high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula during the 3-min CSST and endurance shuttle walking test. |
Device: Automated nasal O2 titration with FreeO2
The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT)
Other Names:
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| Active Comparator: Fixed-flow oxygen therapy The participant received oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). In patients already on home oxygen, the O2 flow during exercise was set at 1 L/min above the usual flow used at home . |
Device: Automated nasal O2 titration with FreeO2
The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Dyspnea score [At the end of the 3 minute-constant speed shuttle test (CSST) (3 minutes), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)]
Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)
Secondary Outcome Measures
- Endurance time duration of the Endurance Shuttle Walking Test (EWST) [Duration in (mm:ss) of Endurance Shuttle Walking Test (ESWT), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)]
Total duration of Endurance Shuttle Walking Test
- Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST) [From the beginning to the end of the Endurance Shuttle Walking Test (ESWT) which will be done on 3 testing days, with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow]
Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)
Other Outcome Measures
- Mean pulsed O2 saturation (SpO2) during 3min-CSST [From the beginning to the end of the 3 minute-constant speed shuttle test which will be done on 3 testing days with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow)]
The mean % pulsed O2 saturation (SpO2) during the test duration time
- Capillary blood gases [Difference the baseline capillary PCO2 from the resting values (before Endurance Shuttle Walking Test - ESWT) to the end of exercise values (after the Endurance Shuttle Walking Test - ESWT) immediately after the intervention]
Carbon dioxide partial pressure (PCO2), lactate
Eligibility Criteria
Criteria
Inclusion Criteria:
One of them
-
Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) < 80% predicted and FEV1/forced vital capacity (FVC) ratio < 0.7)
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Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
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Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure > 25 mm Hg at right heart catheterization
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Cystic fibrosis, as diagnosed by a positive sweat test (>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.
AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test < 88%
Exclusion Criteria:
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Exacerbation of the primary lung disease in the past 8 weeks
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Exercise limiting diseases other than the primary lung disease.
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Not reaching the target dyspnea score during the walking tests.
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Stage 1 pulmonary sarcoidosis
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History of syncope on exertion
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SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
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Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
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Disabling or severe rheumatological or neurological condition
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Participation in a pulmonary rehabilitation program within the last year
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Patients with multi-resistant bacteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Quebec | Canada | G1V4G5 |
Sponsors and Collaborators
- Laval University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau É, Bernard E, Bernard S, Maltais F. Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium versus tiotropium: the RED trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620939507. doi: 10.1177/1753466620939507.
- Maltais F, Aumann JL, Kirsten AM, Nadreau É, Macesic H, Jin X, Hamilton A, O'Donnell DE. Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD. Eur Respir J. 2019 Mar 28;53(3). pii: 1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar.
- Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9.
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