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

Complication,Postoperative Clinical Trial

— WARD-RCT-SX  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640415
• Other study ID #: H-20034555
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication,Postoperative
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital, Bispebjerg Hospital, Odense University Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Length of hospital stay	30 postoperative days and 6 months
Other	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
Other	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
Primary	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	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.
Secondary	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
Secondary	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

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