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

NCT03660501 | Completed

• 1 other identifier: WARD-COPD_v1.1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Continuous monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality

  within 6 months after inclusion

• Readmission

  within 6 months after inclusion

Interventions

Continuous monitoring system DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients admitted with AECOPD
• Recruitment and monitoring start is possible within 24 hours after admission

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Technical University of Denmark: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (2)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35593967 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Troponin, Arterial Blood Gas

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Meyhoff, MD, PHD

  Bispebjerg and Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: September 12, 2018
• Primary Completion: December 21, 2019
• Study Completion: June 21, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)