Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? (WARD-OT)

April 2, 2025 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark

Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? - a Sub-study of Randomized Clinical Trials

This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Eske Kvanner Aasvang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Patients from WARD - RCT.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: inactive alarms
Patients with continuous monitoring without active alerts from WARD.
Experimental: active alarms
Patients with continuous monitoring with active alerts from WARD.
Device: Active alarms from WARD software
Wireless continuous vital sign monitoring with real time staff alerts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of patients having at least one of the following tests/treatments:
Time Frame: 72 hours
  • CT-scans
  • MRi-Scans
  • PET-Scans
  • X-ray (ordered by attending doctor, besides standard procedural investigations)
  • ultrasounds
  • Antibiotics (ordered by attending doctor, besides standard procedural treatment)
  • Arterial puncture
  • Gastro- colonoscopy
  • Dialysis
  • Central venous line (incl. dialysis catheter)
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of individual treatments and diagnostics:
Time Frame: 72 hours

Treatments:

  • Antibiotics (ordered by attending doctor, besides standard procedural treatment)
  • CPAP
  • blood-transfusion
  • IV-fluids
  • Dialysis
  • Naso-gastric tube (ordered by attending doctor, besides standard procedural treatment)
  • Central venous line (incl. dialysis catheter)

Diagnostics:

  • Imaging CT, X-ray, MRI, PET, and ultrasound.
  • Blood tests: arterial blood gases, cultures, and other blood sample tests.
  • ECG
  • cultures from urine, sputum, swabs, and feces.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 2, 2025

Study Completion (Actual)

April 2, 2025

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WARD - Overtreatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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