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NCT06361862 Clinical Trial

Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?

Cancer Clinical Trial

— WARD-OT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06361862
Other study ID # WARD - Overtreatment
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date April 1, 2025

Study information
Verified date April 2024
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • Patients from WARD - RCT. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Active alarms from WARD software
Wireless continuous vital sign monitoring with real time staff alerts

Locations
Country Name City State
Denmark Eske Kvanner Aasvang Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of patients having at least one of the following tests/treatments: 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 The frequency of individual treatments and diagnostics: 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
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