Study of Physiological Signals During and After COPD Exacerbations

Not Applicable

Completed

• Conditions: COPD; COPD Exacerbation
• Interventions: Device: Monitoring of cardiorespiratory parameters with BORA Band

• Registration Number: NCT04034901
• Lead Sponsor: Biosency

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2021-02-19
• Primary Completion: 2024-02-06
• Study Completion: 2024-02-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monitoring of cardiorespiratory parameters	Monitoring of cardiorespiratory parameters with BORA Band	Monitoring of cardiorespiratory parameters with BORA Band

Primary Outcome Measures

Name	Time	Method
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
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 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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Chru Pontchaillou; 🇫🇷 Rennes, France