Study of Physiological Signals During and After COPD Exacerbations (DACRE)
Primary Purpose
COPD, COPD Exacerbation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monitoring of cardiorespiratory parameters with BORA Band
Sponsored by
About this trial
This is an interventional basic science trial for COPD
Eligibility Criteria
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
Sites / Locations
- Chru PontchaillouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monitoring of cardiorespiratory parameters
Arm Description
Monitoring of cardiorespiratory parameters with BORA Band
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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)
Patient satisfaction
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.
Full Information
NCT ID
NCT04034901
First Posted
June 28, 2019
Last Updated
July 19, 2022
Sponsor
Biosency
Collaborators
Slb Pharma, Air de Bretagne, Rennes University Hospital, Centre Hospitalier Bretagne Atlantique, Centre Hospitalier de Saint-Malo, Centre Hospitalier de Saint-Brieuc
1. Study Identification
Unique Protocol Identification Number
NCT04034901
Brief Title
Study of Physiological Signals During and After COPD Exacerbations
Acronym
DACRE
Official Title
Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosency
Collaborators
Slb Pharma, Air de Bretagne, Rennes University Hospital, Centre Hospitalier Bretagne Atlantique, Centre Hospitalier de Saint-Malo, Centre Hospitalier de Saint-Brieuc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, COPD Exacerbation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitoring of cardiorespiratory parameters
Arm Type
Experimental
Arm Description
Monitoring of cardiorespiratory parameters with BORA Band
Intervention Type
Device
Intervention Name(s)
Monitoring of cardiorespiratory parameters with BORA Band
Intervention Description
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
Primary Outcome Measure Information:
Title
Variation of heart rate during and after a COPD acute exacerbation
Description
Average heart rate in beats per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Time Frame
2 months
Title
Variation of respiratory rate during and after a COPD acute exacerbation
Description
Average respiratory rate in cycles per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Time Frame
2 months
Title
Variation of SpO2 during and after a COPD acute exacerbation
Description
Average SpO2 in percent during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Time Frame
2 months
Title
Variation of skin temperature during and after a COPD acute exacerbation
Description
Average skin temperature in celcius during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Time Frame
2 months
Title
Variation of patient activity during and after a COPD acute exacerbation
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Connected wrist-worn pulse oximeter adherence
Description
The mean duration of bora band utilization will be measured (mean number of days and mean number of hours per day)
Time Frame
2 months
Title
Patient satisfaction
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quentin Bodinier, Ph.D.
Phone
973248810
Ext
+33
Email
quentin.bodinier@biosency.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure Serandour, Pharm.D.
Phone
299121962
Ext
+33
Email
al.serandour@slbpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graziella Brinchault, M.D.
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chru Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graziella Brinchault, MD
Phone
0299282478
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Physiological Signals During and After COPD Exacerbations
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