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

Cardiac Disease Clinical Trial

Official title:

WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Hospitalized Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05378139
• Other study ID #: 2203648
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: December 22, 2023

Study information

• Verified date: June 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3095
• Est. completion date: December 22, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Hematologic Diseases
• Infections
• Oncology
• Pulmonary Disease
• Surgical Complication

Intervention

Device:
• Vital signs measurements with new app
Patients vital signs are monitored through an app for the nurses to use

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data quality	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)	30 days
Primary	user satisfaction	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)).	30 days