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Clinical Trials/NCT03660501
NCT03660501
Completed
Not Applicable

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

University Hospital Bispebjerg and Frederiksberg2 sites in 1 country200 target enrollmentSeptember 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University Hospital Bispebjerg and Frederiksberg
Enrollment
200
Locations
2
Primary Endpoint
Any serious adverse events
Status
Completed
Last Updated
5 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
September 12, 2018
End Date
June 21, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Responsible Party
Principal Investigator
Principal Investigator

Mikkel Elvekjaer

MD

University Hospital Bispebjerg and Frederiksberg

Eligibility 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  • Active therapy withdrawn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

Outcomes

Primary Outcomes

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 Outcomes

  • Readmission(within 6 months after inclusion)
  • Mortality(within 6 months after inclusion)

Study Sites (2)

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