Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward.

Clinical Deterioration Clinical Trial

— COCOMO  

Official title:

Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189653
• Other study ID #: 2018-4330
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2019
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.

The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3896
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission on Inclusion ward.

Exclusion Criteria:

• Opt out of file study

Related Conditions & MeSH terms

• Clinical Deterioration

Intervention

Other:
• Continuous Monitoring
Wireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT)

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unexpected Intensive Care Unit Admissions	Unexpected Intensive Care Unit Admissions	During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Primary	Rapid Response Team Activations	Rapid Response Team Activations	During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Secondary	Length of Stay	Length of stay on the ward, ICU and Hospital stay as whole	During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.