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Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.

NCT04640415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-06-18

No results posted yet for this study

Summary

The primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery.

We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.

Conditions

  • Complication,Postoperative

Interventions

DEVICE

Active Alarms

Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    collaborator OTHER

  • Technical University of Denmark

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Jesper Mølgaard, MD · Rigshospitalet, Denmark

  • Eske K Aasvang, MD, DMSc · Rigshospitalet, Denmark

  • Christian S Meyhoff, MD, PhD · Bispebjerg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-10-30
Completion
2023-05-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640415 on ClinicalTrials.gov