Study of Physiological Signals During and After COPD Exacerbations (DACRE)

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

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

Study Overview

• Status: Completed
• Conditions: COPD; COPD Exacerbation
• Intervention / Treatment: Device: Monitoring of cardiorespiratory parameters with BORA Band

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Chru Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitoring of cardiorespiratory parameters; Monitoring of cardiorespiratory parameters with BORA Band	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Biosency
• Collaborators: Rennes University Hospital; Slb Pharma; Air de Bretagne; Centre Hospitalier Bretagne Atlantique; Centre Hospitalier de Saint-Malo; Centre Hospitalier de Saint-Brieuc
• Investigators: Principal Investigator: Graziella Brinchault, M.D., Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2019-A00642-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No