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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Cumulative duration
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
No alarms
Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff.
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.
Intervention: Active Alarms (Device)
Outcomes
Primary Outcomes
Cumulative duration
Time Frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.
Secondary Outcomes
- Frequency of sustained deviation alerts(During monitoring, for a maximum of up to 5 postoperative days or until discharge.)
- Any adverse event(7 days and 30 days after start of monitoring)
- Any serious adverse event(7 days and 30 days after start of monitoring)
Investigators
Jesper Mølgaard
MD, Ph.d student
Rigshospitalet, Denmark