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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03660501
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : April 11, 2019
Technical University of Denmark
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Mikkel Elvekjaer, University Hospital Bispebjerg and Frederiksberg

Brief Summary:
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 27/7 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).

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: Continuous monitoring system

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Vital Sign Monitoring During Admission for Acute Exacerbations of Chronic Obstructive Pulmonary Disease - an Observational Study
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Continuous monitoring system
    Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor, Nonin WristOx 3150, Empatica E4, and Radiometer TCM5 FLEX monitor.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Mortality [ Time Frame: within 6 months after inclusion ]
  2. Readmission [ Time Frame: within 6 months after inclusion ]

Biospecimen Retention:   Samples Without DNA
Troponin, Arterial Blood Gas

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03660501

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Contact: Mikkel Elvekjaer, MD +4531190490

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Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Mikkel Elvekjaer, MD    +4531190490   
Contact: Christian Meyhoff, MD, PHD    +4522985042   
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Jens Ulrik Jensen, MD, PHD   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Technical University of Denmark
Herlev and Gentofte Hospital
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Study Chair: Christian Meyhoff, MD, PHD Bispebjerg and Frederiksberg Hospital

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Responsible Party: Mikkel Elvekjaer, MD, University Hospital Bispebjerg and Frederiksberg Identifier: NCT03660501     History of Changes
Other Study ID Numbers: WARD-COPD_v1.1
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mikkel Elvekjaer, University Hospital Bispebjerg and Frederiksberg:
Continuous monitoring

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases