Clinical trial NCT04640415: Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication,Postoperative
Keywords: Wireless Monitoring
Vital signs
Physiologic deterioration
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Bispebjerg Hospital
name: Technical University of Denmark
First posted: 2020-11-23
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Cumulative duration
timeFrame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Secondary outcomes:
measure: Frequency of sustained deviation alerts
timeFrame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
measure: Any adverse event
timeFrame: 7 days and 30 days after start of monitoring
measure: Any serious adverse event
timeFrame: 7 days and 30 days after start of monitoring
Other outcomes:
measure: Length of hospital stay
timeFrame: 30 postoperative days and 6 months
measure: Patient related post-admission healthcare expenses
timeFrame: 2 years
measure: Staff response time (intervention group only)
timeFrame: During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper Mølgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, MD, DMSc
role: STUDY_CHAIR
affiliation: Bispebjerg
name: Christian S Meyhoff, MD, PhD
role: STUDY_CHAIR
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