NCT04661748

Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards

Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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%.

Conditions

• Alert Fatigue, Health Personnel
• Deterioration, Clinical

Interventions

Type	Name	Description
DEVICE	real time alarm of deviating vital signs	Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds

Timeline

• Start date: 2022-01-07
• Primary completion: 2023-12-23
• Completion: 2024-12-31
• First posted: 2020-12-10
• Last updated: 2025-04-11

Locations

1 site across 1 country: Denmark