Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System

NCT06269198 | Recruiting DMC

• 1 other identifier: WARD - SX - RCT II
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Complications; Cancer, Treatment-Related

Keywords

vital signs; continuous monitoring; wireless monitoring; postoperative physiology; postoperative complications

Outcome Measures

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).

  30 days after surgery

Secondary Outcomes (6)

• Overall complication severity - 7 days

  7 days after surgery

• Frequency of Serious adverse events

  30 days after surgery

• Days alive and out of hospital

  30 days after surgery

• Days alive and out of hospital

  6 months after surgery

• Time to initiation of post-operative adjuvant chemotherapy

  Outcomes will be collected up to 2 year after surgery

Other Outcomes (5)

• Frequency of severe clinical complications

  30 days after surgery

• ICU admission

  30 days after surgery.

• Surgical reintervention of any kind

  30 days after primary-surgery

Study Arms (2)

Control arm

NO INTERVENTION

Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff

Intervention arm

EXPERIMENTAL

Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization

Device: WARD-CSS

Interventions

WARD-CSS DEVICE

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.

Also known as: Continuous vital signs monitoring with real-time alerts

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (3)

Copenhagen University hospital - Rigshospitalet

Copenhagen, Other (Non US), 1665, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, Other (Non US), 2400, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Other (Non US), 2650, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms

Study Officials

• Jesper Mølgaard, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Mølgaard, PhD

CONTACT

+4535453545; moelgaard.jesper@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal investigator

Model Details: Randomisation stratified by study site

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: October 31, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)