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OpenTrials
Completed

NCT Number: NCT04189653

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission on Inclusion ward.

Exclusion criteria

  • Opt out of file study

Treatment and study plan

Continuous Monitoring

Other

Wireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT)

Primary outcomes

  1. Unexpected Intensive Care Unit Admissions

    Time frame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.

    Unexpected Intensive Care Unit Admissions

  2. Rapid Response Team Activations

    Time frame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.

    Rapid Response Team Activations

Secondary outcomes

  1. Length of Stay

    Time frame: During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.

    Length of stay on the ward, ICU and Hospital stay as whole

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: COCOMO

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 6, 2019
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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