Clinical trial NCT03660501: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - an Observational Study
Official title: Continuous Vital Sign Monitoring During Admission for Acute Exacerbations of Chronic Obstructive Pulmonary Disease - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Continuous monitoring
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Herlev and Gentofte Hospital
First posted: 2018-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


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* Active therapy withdrawn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

Primary outcomes:
measure: Any serious adverse events
timeFrame: within 30 days after inclusion
Secondary outcomes:
measure: Mortality
timeFrame: within 6 months after inclusion
measure: Readmission
timeFrame: within 6 months after inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Christian Meyhoff, MD, PHD
role: STUDY_CHAIR
References:
citation: Elvekjaer M, Rasmussen SM, Gronbaek KK, Porsbjerg CM, Jensen JU, Haahr-Raunkjaer C, Molgaard J, Sogaard M, Sorensen HBD, Aasvang EK, Meyhoff CS. Clinical impact of vital sign abnormalities in patients admitted with acute exacerbation of chronic obstructive pulmonary disease: an observational study using continuous wireless monitoring. Intern Emerg Med. 2022 Sep;17(6):1689-1698. doi: 10.1007/s11739-022-02988-w. Epub 2022 May 20.