Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- WARD-CSS
Treatment groups
504 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Bispebjerg Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Source ClinicalTrials.gov