Cancer, Treatment-Related, Postoperative Complications
Conditions
Keywords
vital signs, continuous monitoring, wireless monitoring, postoperative physiology, postoperative complications
Brief 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.
Detailed description
The primary objective of this study is to determine the effect on complication severity of using the WARD-CSS with automatic alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery. This study is a multicenter randomized controlled trial (RCT). Patients are randomly assigned to one of two parallel monitoring groups: (1)Intervention group - Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization. (2)Control group - Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff. Both groups will receive routine vital signs monitoring (i.e. manual spot-checks) using the regional EWS/TOKS system according to current standards of care at the participating hospitals in the Capital Region or the Central Denmark Region. The study is a collaboration between Rigshospitalet, Bispebjerg and Frederiksberg Hospital, and Hvidovre Hospital. Patients will be recruited from abdominal (gastrointestinal, gynecological, or urological) surgery wards at the study sites. Patients will be randomized post-surgery at the postoperative units/ post-anesthesia-care unit or after arrival at the ward. Continuous wireless monitoring (i.e., unblinded with alerts or blinded) will commence immediately after randomization in the study. Only randomized patients will be included in the study population. Drop-outs prior to randomization will not be part of the study population. The first 14 days of active enrollment at each new study site that has not previously used WARD-CSS will be used to align study procedures, verify system connectivity, etc. During this period, up to ten patients at each study site will be enrolled to be monitored similar to the intervention group. These run-in patients will not be randomized and will not be considered part of the study population.
Interventions
DEVICEWARD-CSS
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.
Sponsors
Bispebjerg Hospital
Hvidovre University Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention. Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance. Outcome assessor will be blinded to study allocation.
Intervention model description
Randomisation stratified by study site
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall complication severity - 30 days | 30 days after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall complication severity - 7 days | 7 days after surgery | 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). |
| Frequency of Serious adverse events | 30 days after surgery | 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 |
| Days alive and out of hospital | 30 days after surgery | Number of days alive and out of hospital |
| Time to initiation of post-operative adjuvant chemotherapy | Outcomes will be collected up to 2 year after surgery | For patients scheduled to recieve postoperative chemotherapy, this is the time from surgery to initiation of post-operative adjuvant chemotherapy |
| Completion of post-operative adjuvant chemotherapy | Outcomes will be collected up to 2 year after surgery | For patients scheduled to recieve postoperative chemotherapy, this is the number of patients that complete their post-operative adjuvant chemotherapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU admission | 30 days after surgery. | Number of patients with unplanned admission to the intensive care unit after surgery |
| Surgical reintervention of any kind | 30 days after primary-surgery | Any unplanned surgical reintervention of any kind. |
| Post-discharge readmission | 6 months after surgery. | Re-admission for any reason related to the operation or their respective cancer |
| Health-economic cost-effectiveness. | 2 years after surgery. | Health-economic cost-effectiveness. Data will be collected from all available health care databases in the danish public health care system (ie. use of general practitioners, hospital admissions, hospital registered costs and services, work-leave periods) for a maximum follow up period of 2 years after primary surgery and analyzed when full datasets are available |
| Frequency of severe clinical complications | 30 days after surgery | Frequency of severe clinical complications Defined as any complication fulfilling the Clavien-Dindo classification ≥2 |
Countries
Denmark
Contacts
Primary ContactJesper Mølgaard, PhD
Outcome results
None listed