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Completed

NCT Number: NCT03660501

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

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Active therapy withdrawn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

Treatment and study plan

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.

Primary outcomes

  1. Any serious adverse events

    Time frame: 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 outcomes

  1. Mortality

    Time frame: within 6 months after inclusion

  2. Readmission

    Time frame: within 6 months after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Herlev and Gentofte Hospital
  • Technical University of Denmark

Registry information

Official study title

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

Acronym: WARD-COPD

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2018
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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