Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - an Observational Study (WARD-COPD)

August 26, 2020 updated by: Mikkel Elvekjaer, University Hospital Bispebjerg and Frederiksberg

Continuous Vital Sign Monitoring During Admission for Acute Exacerbations of Chronic Obstructive Pulmonary Disease - an Observational Study

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission with acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 patients admitted to hospital with acute exacerbation of COPD will be included in the study upon arrival to the medical ward.

Description

Inclusion Criteria:

  • Adult patients admitted with AECOPD
  • Recruitment and monitoring start is possible within 24 hours after admission

Exclusion Criteria:

  • Patient expected not to cooperate
  • Patient allergic to plaster, plastic or silicone
  • Active therapy withdrawn
  • Patients with dementia or not able to give informed consent
  • Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
  • Expected discharge within less than 24 hours from possible inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any serious adverse events
Time Frame: within 30 days after inclusion
E.g. cardiac arrest, ICU admission, acute myocardial infarction, stroke, sepsis, acute kidney injury or other serious adverse events (defined in Protocol Appendix A)
within 30 days after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: within 6 months after inclusion
within 6 months after inclusion
Readmission
Time Frame: within 6 months after inclusion
within 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Collaborators

Herlev and Gentofte Hospital
Technical University of Denmark

Investigators

  • Study Chair: Christian Meyhoff, MD, PHD, Bispebjerg and Frederiksberg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2018

Primary Completion (Actual)

December 21, 2019

Study Completion (Actual)

June 21, 2020

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WARD-COPD_v1.1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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