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

Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients - a Part of the Wireless Assessment of Respiratory and Circulatory Distress (WARD) Project

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04305262
Acronym
WARD
Enrollment
0
Registered
2020-03-12
Start date
2020-03-25
Completion date
2020-12-31
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Wireless Vital Parameter Monitoring

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.

Interventions

DEVICEWireless 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

Sponsors

Technical University of Denmark
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Serious desaturationmore than 10 minutes, within the first four days of acute admissionSpO2 \<85% in 10 consecutive minutes

Secondary

MeasureTime frameDescription
tachycardiaone minute within the first four days of admissionHeartrate \>130/min
bradycardiaone minute within the first four days of admissionheartrate \>41/min
tachypneaone minute within the first four days of admissionRespiration rate \>24/min
desaturationmore than 60 minutes, within the first four days of acute admissionSpO2 \<92% in 60 consecutive minutes
hypotensionone measurement within the first four days of admissionSystolic blood pressure \<90 mmHg
hypertensionone measurement wihtin the first four days of admissionsystolic blood pressure \>219 mmHg
bradypneaone minute within the first four days of admissionRespiration rate \<9/min

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026