Continuous Monitoring on the General Ward
Condition: Carcinoma, Pancreatic Ductal; Colorectal Neoplasms; Arthritis; Hypertension; Sepsis
MeSH terms: Colorectal Neoplasms; Carcinoma, Pancreatic Ductal
Study type: Interventional

Summary: 
      Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For
      this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is
      used. Although the MEWS provides relevant data on patients' health status, the interval
      measurements may not capture early deterioration of vital signs, especially during the night.
      As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac
      arrhythmias, which are known to complicate postoperative course. Besides, this way of
      measuring vital signs may be stressful for patients and disturbs patients' sleep. New
      technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of
      vital signs using wearable devices transmitting relevant data to nurses and clinicians. With
      this, the investigators think that clinical deterioration may be detected in an early phase
      and reduce nurse work load and patient distress.

      Objective: to investigate the feasibility of wearable devices on the general ward.

      Study design: feasibility study.

      Study population: adult patients hospitalized on the internal medicine ward and adult
      postoperative patients on the surgical ward.

      Intervention: patients in the intervention groups will be randomized in one of the two
      groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the
      HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements
      take place at usual time points.

      Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome
      measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS
      measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side
      effects of devices, STAI scores, and PCS scores will be documented.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Patients will wear one device for at least three days. Devices can be
      uncomfortable by being heavy or the patches can start itching. More measurements by nurses
      can take place when indicated, for example after alarms. The participating patients will fill
      out the STAI on daily basis and the PCS on the last day of hospitalization. Both
      questionnaires will take a few minutes to complete. Patients could benefit from early
      detection of clinical deterioration and early corrective interventions or ICU admissions.
    


Intervention name(s): HealthPatch; ViSi Mobile
Intervention type(s): Device; Device
Intervention description(s): The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps; ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention