Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration. (WARD-RCT-SX)

Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients After Major Surgery. A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Complication,Postoperative
• Intervention / Treatment: Device: Active Alarms

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Copenhagen
    • Copenhagen NV, Copenhagen, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
• Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
• Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively

Exclusion Criteria:

• Patient expected not to cooperate with study procedures.
• Allergy to plaster or silicone.
• Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination] score < 24)
• Patients admitted for palliative care only (i.e. no active treatment).
• Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
• Patients previously enrolled in the medical WARD RCT.
• Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
• Inability to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No alarms; Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff.
Active Comparator: Active alarms; Patients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative duration	Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.	During monitoring, for a maximum of up to 5 postoperative days or until discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of sustained deviation alerts	Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol.	During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Any adverse event	Any adverse event. Criteria for each defined in protocol. Results will be compared between the case and control arm, on when it a diagnosis is made. Based on information in patient electronic medical file.	7 days and 30 days after start of monitoring
Any serious adverse event	Any serious adverse event. Criteria for each defined in protocol. Serious Adverse Events will be determined using the criteria as defined in ICH-GCP terms. Results will be compared between the case and control arm, on when it a diagnosis is made. Based on information in patient electronic medical file.	7 days and 30 days after start of monitoring

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay	30 postoperative days and 6 months
Patient related post-admission healthcare expenses	Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses	2 years
Staff response time (intervention group only)	Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day	During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Aarhus University Hospital; Bispebjerg Hospital; Technical University of Denmark
• Investigators: Principal Investigator: Jesper Mølgaard, MD, Rigshospitalet, Denmark; Study Chair: Eske K Aasvang, MD, DMSc, Rigshospitalet, Denmark; Study Chair: Christian S Meyhoff, MD, PhD, Bispebjerg

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Vital signs; Wireless Monitoring; Physiologic deterioration
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: H-20034555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No