Complication,Postoperative
Conditions
Keywords
Wireless Monitoring, Vital signs, Physiologic deterioration
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.
Interventions
DEVICEActive 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.
Sponsors
Aarhus University Hospital
Odense University Hospital
Bispebjerg Hospital
Technical University of Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative duration | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of sustained deviation alerts | During monitoring, for a maximum of up to 5 postoperative days or until discharge. | Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol. |
| Any adverse event | 7 days and 30 days after start of monitoring | 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. |
| Any serious adverse event | 7 days and 30 days after start of monitoring | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient related post-admission healthcare expenses | 2 years | Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses |
| Staff response time (intervention group only) | During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first | Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day |
| Length of hospital stay | 30 postoperative days and 6 months | Length of hospital stay |
Countries
Denmark
Outcome results
None listed