Clinical trial NCT04034901: Study of Physiological Signals During and After COPD Exacerbations
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
Overall status: COMPLETED
Phase: NA
Conditions: COPD
COPD Exacerbation
Lead sponsor: Biosency
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
name: Air de Bretagne
name: Rennes University Hospital
name: Centre Hospitalier Bretagne Atlantique
name: Centre Hospitalier de Saint-Malo
name: Centre Hospitalier de Saint-Brieuc
First posted: 2019-07-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Variation of heart rate during and after a COPD acute exacerbation
timeFrame: 2 months
measure: Variation of respiratory rate during and after a COPD acute exacerbation
timeFrame: 2 months
measure: Variation of SpO2 during and after a COPD acute exacerbation
timeFrame: 2 months
measure: Variation of skin temperature during and after a COPD acute exacerbation
timeFrame: 2 months
measure: Variation of patient activity during and after a COPD acute exacerbation
timeFrame: 2 months
Secondary outcomes:
measure: Connected wrist-worn pulse oximeter adherence
timeFrame: 2 months
measure: Patient satisfaction
timeFrame: 2 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Chru Pontchaillou
Study officials:
affiliation: CHU Rennes
name: Graziella Brinchault, M.D.
role: PRINCIPAL_INVESTIGATOR
References: