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Clinical Trials/NCT03467815
NCT03467815CompletedNot Applicable

Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - A Pilot Study

Bispebjerg Hospital1 site in 1 country30 target enrollmentStarted: March 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm

Study Overview

Brief Summary

For patients admitted to the medical ward, it is usually 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 progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion Criteria

  • Patient expected not to cooperate.
  • Patient allergic to plaster, plastic or silicone.
  • Active therapy withdrawn

Outcomes

Primary Outcomes

Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm

Time Frame: The patients are monitored for 4 days

Hypoxemia: arterial oxygen saturation \< 92 %

Blood pressure resulting in a single parameter score of 3 according to EWS algorithm

Time Frame: The patients are monitored for 4 days

Hypotension: Systolic blood pressure \< 91 mmHg Hypertension: Systolic blood pressure \> 219 mmHg

Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm

Time Frame: The patients are monitored for 4 days

Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min

Heart rate resulting in a single parameter score of 3 according to EWS algorithm

Time Frame: The patients are monitored for 4 days

All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse \< 41 bpm Tachycardia: pulse \> 130 bpm

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mikkel Elvekjaer

M.D.

Bispebjerg Hospital

Study Sites (1)

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