Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 6
- 主要终点
- Overall complication severity - 30 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
Control arm
Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff
Intervention arm
Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization
干预措施: WARD-CSS (Device)
结局指标
主要结局
Overall complication severity - 30 days
时间窗: 30 days after surgery
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).
次要结局
- Days alive and out of hospital(6 months after surgery)
- Completion of post-operative adjuvant chemotherapy(Outcomes will be collected up to 2 year after surgery)
- Overall complication severity - 7 days(7 days after surgery)
- Time to initiation of post-operative adjuvant chemotherapy(Outcomes will be collected up to 2 year after surgery)
- Frequency of Serious adverse events(30 days after surgery)
研究者
Jesper Mølgaard
MD, PhD, Principal investigator
Rigshospitalet, Denmark