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

NCT04189653 | Completed

• 1 other identifier: 2018-4330
• Study Type: observational
• Target: 3,896
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Deterioration

Keywords

Early Warning Scores; Continuous Vital Sign Monitoring; Escalation of Care; ICU-Transfer; Deterioration prevention

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Length of Stay

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

Study Arms (2)

General Ward Inpatients 2017-2018

ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2017-august 31st 2018.

General Ward Inpatients 2018-2019

ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2018-august 31st 2019.

Other: Continuous Monitoring

Interventions

Continuous Monitoring OTHER

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

General Ward Inpatients 2018-2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult general ward patients of the GE-surgery and Internal Medicine wards of a Dutch tertiary academic hospital.

You may not qualify if:

• Opt out of file study

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Clinical Deterioration

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 7, 2022

Record last verified: 2019-11

Locations

NL (1)