Trial Title:
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
NCT ID:
NCT06269198
Condition:
Postoperative Complications
Cancer, Treatment-Related
Conditions: Official terms:
Neoplasms, Second Primary
Postoperative Complications
Conditions: Keywords:
vital signs
continuous monitoring
wireless monitoring
postoperative physiology
postoperative complications
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomisation stratified by study site
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Device
Intervention name:
WARD-CSS
Description:
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.
Arm group label:
Intervention arm
Other name:
Continuous vital signs monitoring with real-time alerts
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.
Criteria for 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.)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Copenhagen University hospital - Rigshospitalet
Address:
City:
Copenhagen
Zip:
1665
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Jesper Mølgaard, PhD
Phone:
+4535453545
Email:
jesper.moelgaard@regionh.dk
Contact backup:
Last name:
Eske K Aasvang, DMSc
Phone:
+4535450802
Email:
eske.kvanner.aasvang.01@regionh.dk
Facility:
Name:
Bispebjerg Hospital
Address:
City:
Copenhagen
Zip:
2400
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Christian S Meyhoff, PhD
Phone:
+4524910542
Email:
christian.sylvest.meyhoff@regionh.dk
Investigator:
Last name:
Christian S Meyhoff, PhD
Email:
Principal Investigator
Facility:
Name:
Hvidovre Hospital
Address:
City:
Hvidovre
Zip:
2650
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Katja B L Glud, RN
Phone:
+4538625713
Email:
katja.balle.levring.glud@regionh.dk
Investigator:
Last name:
Søren Kjær, MD
Email:
Principal Investigator
Start date:
October 31, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Bispebjerg Hospital
Agency class:
Other
Collaborator:
Agency:
Hvidovre University Hospital
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06269198
