COPD, COPD Exacerbation
Conditions
Brief summary
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
Interventions
DEVICEMonitoring of cardiorespiratory parameters with BORA Band
The subjects will continuously wear a connected wrist-worn pulse oximeter which will remotely collect the following measurements : * Activity * Step count * Heart rate * Respiratory rate * Skin temperature * SpO2
Sponsors
Slb Pharma
Air de Bretagne
Rennes University Hospital
Centre Hospitalier Bretagne Atlantique
Centre Hospitalier de Saint-Malo
Centre Hospitalier de Saint-Brieuc
Biosency
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient known or suspected to suffer from COPD * patient admitted in pulmonology unit for COPD exacerbation * patient accepting to use BORA Band during and after hospitalization * patient accepting to be followed by the partner health care provider for this study (Air de Bretagne) * patient able to understand French and express their informed consent * patient affiliated to social security
Exclusion criteria
* patient is intubated * patient already followed by a health care provider other than Air de Bretagne * investigator assesses that the patient will have difficulties following the protocol * patient already enrolled in another interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of respiratory rate during and after a COPD acute exacerbation | 2 months | Average respiratory rate in cycles per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter |
| Variation of skin temperature during and after a COPD acute exacerbation | 2 months | Average skin temperature in celcius during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter |
| Variation of patient activity during and after a COPD acute exacerbation | 2 months | 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 |
| Variation of heart rate during and after a COPD acute exacerbation | 2 months | Average heart rate in beats per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter |
| Variation of SpO2 during and after a COPD acute exacerbation | 2 months | Average SpO2 in percent during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 2 months | 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. |
| Connected wrist-worn pulse oximeter adherence | 2 months | The mean duration of bora band utilization will be measured (mean number of days and mean number of hours per day) |
Countries
France
Outcome results
None listed