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

Chronic Obstructive Pulmonary Disease Clinical Trial

— WARD-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660501
• Other study ID #: WARD-COPD_v1.1
• Status: Completed
• Start date: September 12, 2018
• Est. completion date: June 21, 2020

Study information

• Verified date: August 2020
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 21, 2020
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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• Active therapy withdrawn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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Gentofte Hospital	Hellerup

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Herlev and Gentofte Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any serious adverse events	E.g. cardiac arrest, ICU admission, acute myocardial infarction, stroke, sepsis, acute kidney injury or other serious adverse events (defined in Protocol Appendix A)	within 30 days after inclusion
Secondary	Mortality		within 6 months after inclusion
Secondary	Readmission		within 6 months after inclusion