An interventional study of real time alarm of deviating vital signs in Alert Fatigue, Health Personnel and Deterioration, Clinical, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Prevention
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 cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
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 need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms.
Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the "Early Warning Score (EWS)", "Tidlig Opsporing af Kritisk Sygdom (TOKS)" or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals.
Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.
48 studies on the registry are indexed under Clinical Deterioration; 14 are open to participants now.
This study's enrollment of 300 is close to the median of 300 across 22 interventional studies indexed under Clinical Deterioration.
Browse Clinical Deterioration studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
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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:
OR
○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.
Exclusion Criteria:
Active alarms
Device: real time alarm of deviating vital signs
No alarms
Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● SpO2 \< 85%
Time frame: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
* Respiratory rate ≤ 5 min-1 * Respiratory rate \> 24 min-1
Time frame: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
* Heart rate \> 130 min-1 * Heart rate ≤ 30 min-1
Time frame: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
* Systolic blood pressure ≤ 90 mmHg * Systolic blood pressure \> 220 mmHg
Time frame: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● Atrial fibrillation
Time frame: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● Circulatory failure * Systolic blood pressure \< 100 mmHg AND * Heart rate \>110 min-1 (for more than 30 minutes) OR heart rate \>130 min-1 (for more than 5 minutes) OR heart rate \< 50 (for more than 30 minutes) AND/
Time frame: 5 days after inclusion or until discharge
Frequency and duration of deviations in vital signs
Frequency of each of the deviations in vital signs. List of vital signs, and normal limits detailed in protocol
Time frame: 5 days after inclusion or until discharge
Number of patients with any adverse clinical outcomes
Any adverse events. Criteria for each defined in protocol. Adverse events will be manually categorised as a 'Severe adverse event' (SAE), or simple 'adverse event' (AE).
Time frame: 30 days after inclusion
Length of hospital stay (LOS)
Lenght of hospital stay
Time frame: 6 months after inclusion
Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses
Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses
Time frame: 2 years
Staff response time (interventions group only)
Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day
Time frame: 5 days after inclusion
Plan to share: Undecided
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Bispebjerg and Frederiksberg