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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Complication,Postoperative

Intervention / Treatment
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* Device: Active Alarms


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No alarms<br>Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff. | |
| Active Comparator: Active alarms<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wireless Monitoring, Vital signs, Physiologic deterioration