Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System (WARD-SX-RCT-II)

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Cancer, Treatment-Related
• Intervention / Treatment: Device: WARD-CSS

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.

• Study Type: Interventional
• Enrollment (Estimated): 504
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Mølgaard, PhD; Phone Number: +4535453545; Email: moelgaard.jesper@gmail.com

Study Locations

• Denmark
  • Other (Non US)
    • Copenhagen, Other (Non US), Denmark, 1665
      • Recruiting
      • Copenhagen University Hospital - Rigshospitalet
      • Contact: Jesper Mølgaard, PhD; Phone Number: +4535453545; Email: jesper.moelgaard@regionh.dk
      • Contact: Eske K Aasvang, DMSc; Phone Number: +4535450802; Email: eske.kvanner.aasvang.01@regionh.dk
    • Copenhagen, Other (Non US), Denmark, 2400
      • Recruiting
      • Bispebjerg Hospital
      • Contact: Christian S Meyhoff, PhD; Phone Number: +4524910542; Email: christian.sylvest.meyhoff@regionh.dk
      • Principal Investigator: Christian S Meyhoff, PhD
    • Hvidovre, Other (Non US), Denmark, 2650
      • Not yet recruiting
      • Hvidovre Hospital
      • Contact: Katja B L Glud, RN; Phone Number: +4538625713; Email: katja.balle.levring.glud@regionh.dk
      • Principal Investigator: Søren Kjær, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff
Experimental: Intervention arm; Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization	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.; Other Names: Continuous vital signs monitoring with real-time alerts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days after surgery
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	30 days after surgery
Days alive and out of hospital	Number of days alive and out of hospital	30 days after surgery
Days alive and out of hospital	Number of days alive and out of hospital	6 months after surgery
Time to initiation of post-operative adjuvant chemotherapy	For patients scheduled to recieve postoperative chemotherapy, this is the time from surgery to initiation of post-operative adjuvant chemotherapy	Outcomes will be collected up to 2 year after surgery
Completion of post-operative adjuvant chemotherapy	For patients scheduled to recieve postoperative chemotherapy, this is the number of patients that complete their post-operative adjuvant chemotherapy.	Outcomes will be collected up to 2 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of severe clinical complications	Frequency of severe clinical complications Defined as any complication fulfilling the Clavien-Dindo classification ≥2	30 days after surgery
ICU admission	Number of patients with unplanned admission to the intensive care unit after surgery	30 days after surgery.
Surgical reintervention of any kind	Any unplanned surgical reintervention of any kind.	30 days after primary-surgery
Post-discharge readmission	Re-admission for any reason related to the operation or their respective cancer	6 months after surgery.
Health-economic cost-effectiveness.	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	2 years after surgery.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Hvidovre University Hospital; Bispebjerg Hospital
• Investigators: Principal Investigator: Jesper Mølgaard, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: postoperative complications; vital signs; continuous monitoring; wireless monitoring; postoperative physiology
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Postoperative Complications; Neoplasms, Second Primary
• Other Study ID Numbers: WARD - SX - RCT II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No