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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
| Air de Bretagne | UNKNOWN |
| Rennes University Hospital | OTHER |
| Centre Hospitalier Bretagne Atlantique |
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Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.
Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.
Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged.
Setting : 4 investigative centers across Brittany
Patients : 50 patients will be enrolled in the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring of cardiorespiratory parameters | Experimental | Monitoring of cardiorespiratory parameters with BORA Band |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring of cardiorespiratory parameters with BORA Band | Device | The subjects will continuously wear a connected wrist-worn pulse oximeter which will remotely collect the following measurements :
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of heart rate during and after a COPD acute exacerbation | Average heart rate in beats per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter | 2 months |
| Variation of respiratory rate during and after a COPD acute exacerbation | Average respiratory rate in cycles per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter | 2 months |
| Variation of SpO2 during and after a COPD acute exacerbation | Average SpO2 in percent during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter | 2 months |
| Variation of skin temperature during and after a COPD acute exacerbation | Average skin temperature in celcius during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter | 2 months |
| Variation of patient activity during and after a COPD acute exacerbation | Average patient activity measured in activity duration per day during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Connected wrist-worn pulse oximeter adherence | The mean duration of bora band utilization will be measured (mean number of days and mean number of hours per day) | 2 months |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graziella Brinchault, M.D. | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Pontchaillou | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| Centre Hospitalier de Saint-Malo | UNKNOWN |
| Centre Hospitalier de Saint-Brieuc | OTHER |
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|
the patient satisfaction with the connected wrist-worn pulse oximeter will be assessed using a series of yes or no questions about the comfort, the acceptability, the ease of use and the size of the device.
| 2 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |