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Completed

NCT Number: NCT04034901

Study of Physiological Signals During and After COPD Exacerbations

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

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Key information

Conditions

COPD COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Pontchaillou

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitoring of cardiorespiratory parameters with BORA Band

Device

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

Primary outcomes

  1. Variation of heart rate during and after a COPD acute exacerbation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Connected wrist-worn pulse oximeter adherence

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biosency

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: DACRE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2019
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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