Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Hospitalized Patients

Sponsor
University Hospital Bispebjerg and Frederiksberg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05378139
Collaborator
Rigshospitalet, Denmark (Other)
3,095
55.2

Study Details

Study Description

Brief Summary

The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:

The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Condition or Disease Intervention/Treatment Phase
  • Device: Vital signs measurements with new app

Detailed Description

Over the last years, the applicants and research team partners have developed the WARD (Wireless Assessment of Respiratory and circulatory Distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. The WARD project combines continuous measurements of 10 different physiological modalities with machine learning to develop the WARD-Clinical Support System (WARD-CSS), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. Through a mobile device with a purpose-built Graphic User Interface (GUI), the WARD-CSS stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients.

The WARD project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. Specifically, observational pilot studies of both patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing Early Warning Score (EWS) systems.

Ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. This study will investigate the WARD-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted

Study Design

Study Type:
Observational
Anticipated Enrollment :
3095 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Hospitalized Patients
Anticipated Study Start Date :
May 25, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Outcome Measures

Primary Outcome Measures

  1. Data quality [30 days]

    The number (frequency) of patients having adequate data quality (defined as at least 60% of the monitoring time with simultaneous recording of SpO2, respiratory rate, heart rate)

  2. user satisfaction [30 days]

    Number of users with adequate clinical user satisfaction (defined as the nurse in charge of the patient at the end of monitoring answers "Agree" or "Strongly agree" to the question "WARD-monitoring was beneficial for monitoring of vital signs in this patientparticipant (response options: Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree)).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patient (≥18 years), assessed by the clinical staff as at risk for clinical deterioration
Exclusion Criteria:
  • The patientparticipant expected not to cooperate with study procedures.

  • Allergy to plaster or silicone.

  • Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.

  • Inability to give informed consent.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital Bispebjerg and Frederiksberg
  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katja Kjær Grønbæk, Principal Investigator, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier:
NCT05378139
Other Study ID Numbers:
  • 2203648
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022