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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complication,Postoperative
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Cumulative duration
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Jesper Mølgaard
MD, Ph.d student
Rigshospitalet, Denmark
Eligibility Criteria
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.
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)