Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
NCT ID: NCT06269198
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
504 participants
INTERVENTIONAL
2023-10-31
2027-04-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
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Control arm
Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff
No interventions assigned to this group
Intervention arm
Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Hvidovre University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Jesper Mølgaard
MD, PhD, Principal investigator
Principal Investigators
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Jesper Mølgaard, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Copenhagen University hospital - Rigshospitalet
Copenhagen, Other (Non US), Denmark
Bispebjerg Hospital
Copenhagen, Other (Non US), Denmark
Hvidovre Hospital
Hvidovre, Other (Non US), Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WARD - SX - RCT II
Identifier Type: -
Identifier Source: org_study_id
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