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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds
Bispebjerg and Frederiksberg Hospital
København NV, Region H, Denmark
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
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