NCT06361862

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

January 22, 2024

Last Update Submit

April 2, 2025

Conditions

CancerChronic Obstructive Pulmonary DiseaseSurgery-Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The frequency of individual treatments and diagnostics:

    72 hours

Study Arms (2)

inactive alarms

NO INTERVENTION

Patients with continuous monitoring without active alerts from WARD.

active alarms

EXPERIMENTAL

Patients with continuous monitoring with active alerts from WARD.

Device: Active alarms from WARD software

Interventions

Active alarms from WARD softwareDEVICE

Wireless continuous vital sign monitoring with real time staff alerts

active alarms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from WARD - RCT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eske Kvanner Aasvang

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

NeoplasmsPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, head of research, MD, DmSci

Study Record Dates

First Submitted

January 22, 2024

First Posted

April 12, 2024

Study Start

January 1, 2024

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)