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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT03660501
• Lead Sponsor: 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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Study Start: 2018-09-12
• Primary Completion: 2019-12-21
• Study Completion: 2020-06-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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• Active therapy withdrawn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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any serious adverse events	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

Name	Time	Method
Readmission	within 6 months after inclusion
Mortality	within 6 months after inclusion

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark