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COVID19 pandemia
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| automated nasal oxygen titration with FreeO2 alone | Active Comparator | 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. |
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| automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy | Active Comparator | 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. |
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| Fixed-flow oxygen therapy | Active Comparator | 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated nasal O2 titration with FreeO2 | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea score | Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Endurance time duration of the Endurance Shuttle Walking Test (EWST) | Total duration of Endurance Shuttle Walking Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pulsed O2 saturation (SpO2) during 3min-CSST | The mean % pulsed O2 saturation (SpO2) during the test duration time | 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) |
Inclusion Criteria:
One of them
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Quebec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30655277 | Background | Maltais F, Aumann JL, Kirsten AM, Nadreau E, 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):1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar. | |
| 32663102 | Background |
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The participant was not inform about what kind of oxygen support was provided during exercise
|
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| Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST) |
Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT) |
| 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 |
| Capillary blood gases |
Carbon dioxide partial pressure (PCO2), lactate |
| 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 |
| Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau E, 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. |
| 19863362 | Background | 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. doi: 10.1080/15412550903156317. |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D008171 | Lung Diseases |
| D006976 | Hypertension, Pulmonary |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003550 | Cystic Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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