Status:
COMPLETED
Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
Lead Sponsor:
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Alert Fatigue, Health Personnel
Deterioration, Clinical
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumu...
Detailed Description
Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and ...
Eligibility Criteria
Inclusion
- Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below.
- Adult patients (≥18 years).
- At least one (additional) expected overnight stay.
- High-risk medical admission, defines as EITHER:
- one or more of the following symptoms or tentative diagnoses: Pneumonia, dyspnea, acute coronary syndrome, new onset heart failure or sepsis WITH two or more of the following deviations in vital signs recorded at one time point within 48 hours of admission:
- Respiratory rate ≥ 21 min-1 or ≤ 7 min-1
- Oxygen saturation of arterial hemoglobin ≤ 93 %
- Pulse rate ≥ 111 min-1 or ≤ 40 min-1
- Systolic blood pressure ≤ 100 mmHg or \> 200 mmHg
- Temperature \> 39 °C or ≤ 35,9 °C
- Any alteration in mental status
- Any oxygen supplementation
- OR
- ○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.
Exclusion
- Patient expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Patients admitted for palliative care only (i.e. no active treatment).
- Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
- Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
- Patients previously enrolled in the surgical ward RCT
- A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04661748
Start Date
January 7 2022
End Date
December 31 2024
Last Update
April 11 2025
Active Locations (1)
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1
Bispebjerg and Frederiksberg Hospital
København NV, Region H, Denmark, 2400