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

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ClinicalTrials.gov Identifier: NCT03660501
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborators:
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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03660501


Contacts
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Contact: Mikkel Elvekjaer, MD +4531190490 mikkel.elvekjaer@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Mikkel Elvekjaer, MD    +4531190490    mikkel.elvekjaer@regionh.dk   
Contact: Christian Meyhoff, MD, PHD    +4522985042    christian.sahlholt.meyhoff@regionh.dk   
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Jens Ulrik Jensen, MD, PHD       jens.ulrik.jensen@regionh.dk   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Technical University of Denmark
Herlev and Gentofte Hospital
Investigators
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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
ClinicalTrials.gov 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