DACRE: Study of Physiological Signals During and After COPD Exacerbations

• Sponsor: Biosency (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04034901
• Collaborator: Slb Pharma (Other), Air de Bretagne (Other), Rennes University Hospital (Other), Centre Hospitalier Bretagne Atlantique (Other), Centre Hospitalier de Saint-Malo (Other), Centre Hospitalier de Saint-Brieuc (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COPD; COPD Exacerbation	Device: Monitoring of cardiorespiratory parameters with BORA Band	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO
• Actual Study Start Date: Jan 15, 2021
• Anticipated Primary Completion Date: Jan 15, 2023
• Anticipated Study Completion Date: Jan 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

Secondary Outcome Measures

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chru Pontchaillou	Rennes		France	35000

Sponsors and Collaborators

• Biosency
• Slb Pharma
• Air de Bretagne
• Rennes University Hospital
• Centre Hospitalier Bretagne Atlantique
• Centre Hospitalier de Saint-Malo
• Centre Hospitalier de Saint-Brieuc

Investigators

• Principal Investigator: Graziella Brinchault, M.D., CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosency
• ClinicalTrials.gov Identifier: NCT04034901
• Other Study ID Numbers: 2019-A00642-55
• First Posted: Jul 26, 2019
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 20, 2022