Study of Physiological Signals During and After COPD Exacerbations

COPD Clinical Trial

— DACRE  

Official title:

Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034901
• Other study ID #: 2019-A00642-55
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: July 2022
• Source: Biosency
• Contact: Quentin Bodinier, Ph.D.
• Phone: 973248810
• Email: quentin.bodinier[@]biosency.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Monitoring 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

Locations

Country	Name	City	State
France	Chru Pontchaillou	Rennes

Sponsors (7)

Lead Sponsor	Collaborator
Biosency	Air de Bretagne, Centre Hospitalier Bretagne Atlantique, Centre Hospitalier de Saint-Brieuc, Centre Hospitalier de Saint-Malo, Rennes University Hospital, Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	2 months