Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
Rigshospitalet, Denmark
504 participants
Oct 31, 2023
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery. Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy.
Eligibility
Inclusion Criteria4
- Admission for elective major abdominal (gastrointestinal, gynecological, or urological) surgery with the primary aim of radical surgery/removing suspected cancer tissue.
- At least two expected postoperative admission days
- Laparotomy or laparoscopy procedure estimated to last more than 2 hours.
- Co-enrolment of patients in other studies is acceptable but in studies involving interventions which potentially will affect the continuous monitoring of vital signs and/or the primary or secondary outcomes, an assessment of whether these patients can be co-enrolled in the WARD-RCT should be conferred with the WARD RCT steering committee.
Exclusion Criteria6
- Patient expected not to cooperate with study procedures
- Allergy to study materials (silicone, plaster)
- Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination score < 24). (Protocol Appendix E)
- Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device
- Inability to give informed consent
- Patients with planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or two-stage resections (two-stage hepatectomy, two-stage resection of malignant colorectal obstructions, etc.)
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Interventions
Patients' continuously monitored vital signs will be recorded via a bedside tablet device (data not visible). The clinical staff will have access to the continuously monitored vital signs through a mobile device (smart phone) with a purpose-built app-based GUI displaying vital sign status and summaries, alarms, and device connectivity. The GUI will alert the clinical staff (acoustic and visual signals) when any of the predefined thresholds for deviating vital signs are exceeded.
Locations(3)
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NCT06269198