Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients

NCT ID: NCT04305262

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-25
• Study Completion Date: 2020-12-31

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 project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.

Conditions

Continuous Wireless Vital Parameter Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Wireless continuous vital parameter monitoring

The patients included in this study will have continuous, wireless monitoring of vital parameters during the first four days of acute admission

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults >18 years
• Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
• Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
• One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
• Inclusion conversation possible within 12 hours of admission or discharge from ICU

Exclusion Criteria

• Patients that cannot cooperate
• Patients that cannot give informed consent
• Patients with EWS≥4 that is not of presumed physical origin
• Patients with allergies to plaster or silicone
• Patients with pacemaker or ICD
• Patients with treatment limitations (no resuscitation or no admission to ICU)
• Patients with expected discharge within 24 hours
• Patients that have been included in the WARD-COPD study (H-18026653)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Katja Kjær Grønbæk

MD, PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Meyhoff, MD, PhD

Role: STUDY_CHAIR

Bispebjerg Hospital

Katja Grønbæk, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Other Identifiers

H-19086056

Identifier Type: -

Identifier Source: org_study_id