Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System

Official title

Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial

Overview

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

• Device WARD-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.

Primary outcome measures

• Overall complication severity - 30 days [Time frame: 30 days after surgery]

Secondary outcome measures (6)

• Overall complication severity - 7 days [Time frame: 7 days after surgery]
• Frequency of Serious adverse events [Time frame: 30 days after surgery]
• Days alive and out of hospital [Time frame: 30 days after surgery]
• Days alive and out of hospital [Time frame: 6 months after surgery]
• Time to initiation of post-operative adjuvant chemotherapy [Time frame: Outcomes will be collected up to 2 year after surgery]
• Completion of post-operative adjuvant chemotherapy [Time frame: Outcomes will be collected up to 2 year after surgery]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Denmark · 3 centers

• Copenhagen University hospital - Rigshospitalet — Copenhagen
• Bispebjerg Hospital — Copenhagen
• Hvidovre Hospital — Hvidovre

Identifiers

NCT: NCT06269198 · WARD - SX - RCT II

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗