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| Name | Class |
|---|---|
| Hospitales Universitarios Virgen del RocÃo | OTHER |
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Objectives:
Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ≤ 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2 >85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined.
Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded.
Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula oxygen therapy | Other |
| |
| Standard oxygen therapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | High-flow nasal cannula oxygen therapy vs. standard oxygen therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endurance time | Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy | through study completion, an average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea and fatigue | Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy | through study completion, an average of 1 week |
| Oxygen saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Balcells Vilarnau | Hospital del Mar | Principal Investigator |
| Diego AgustÃn Rodriguez Chiariadia | Hospital del Mar | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
| through study completion, an average of 1 week |
| Muscle oxygen saturation (StO2) | Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy | through study completion, an average of 1 week |