Clinical Deterioration Clinical Trial
— COCOMOOfficial title:
Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.
NCT number | NCT04189653 |
Other study ID # | 2018-4330 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | August 1, 2020 |
Verified date | November 2019 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
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. |
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