NCT06269198

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Complications
• Cancer, Treatment-Related

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-31
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2024-02-21
• Last updated: 2025-01-15

Locations

3 sites across 1 country: Denmark