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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
WARD-CSS
DevicePatients' 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.
Treatment groups
504 Participants
are divided into 2 treatment groupsGroup A: Control armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall complication severity - 30 days
Severity of complications assessed by the Comprehensive Complication Index (CCI) score. Complications are defined according to internationally agreed definitions of complications. CCI can take on numerical values in the scale from 0 (no complications) to 100 (patient deceased).
Time frame
30 days after surgerySecondary outcomes
1
Overall complication severity - 7 days
Severity of complications assessed by the Comprehensive Complication Index (CCI) score. Complications are defined according to internationally agreed definitions of complications. CCI can take on numerical values in the scale from 0 (no complications) to 100 (patient deceased).
Time frame
7 days after surgery2
Frequency of Serious adverse events
Frequency of Serious adverse events (SAE) SAE is defined by ICH-GCP criteria as: Any unfavourable medical occurrence that * results in death * is life-threatening * requires inpatient hospitalisation or prolongation of existing hospitalisation * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect
Time frame
30 days after surgery3
Days alive and out of hospital
Number of days alive and out of hospital
Time frame
30 days after surgery4
Days alive and out of hospital
Number of days alive and out of hospital
Time frame
6 months after surgeryOther outcomes
1
Frequency of severe clinical complications
Frequency of severe clinical complications Defined as any complication fulfilling the Clavien-Dindo classification ≥2
Time frame
30 days after surgery2
ICU admission
Number of patients with unplanned admission to the intensive care unit after surgery
Time frame
30 days after surgery.3
Surgical reintervention of any kind
Any unplanned surgical reintervention of any kind.
Time frame
30 days after primary-surgery4
Post-discharge readmission
Re-admission for any reason related to the operation or their respective cancer
Time frame
6 months after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Bispebjerg Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Source ClinicalTrials.gov