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

Rigshospitalet, Denmark400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

400

Conditions

Complication,Postoperative

Interventions

Active AlarmsDEVICE

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (2)

Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Cumulative duration

Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.

Time frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 7 days and 30 days after start of monitoring

Data from ClinicalTrials.gov

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