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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2023-05-30

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.

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Detailed Description

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Conditions

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Complication,Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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No alarms

Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Active Alarms

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No