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OpenTrials
Completed

NCT Number: NCT02933307

Continuous Monitoring on the General Ward

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is 18 years or older on the day the informed consent will be signed.
  • Patient is hospitalized on the surgical or internal medicine ward.
  • MEWS measurements are required at least three times a day.
  • Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion criteria

  • Frequency of MEWS measurements is less than three times a day.

Treatment and study plan

HealthPatch

Device

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

Device

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.

Primary outcomes

  1. Expectations & experiences of patients

    Time frame: 2-3 days after informed consent

    Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group

  2. Expectations & experiences of care givers

    Time frame: 1 year

    Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses

Secondary outcomes

  1. MEWS scores based on continuous data and data measured by nurses

    Time frame: 3 times a day, up to three days.

  2. Amount of alarms by HealthPatch or ViSi Mobile

    Time frame: during 2-3 days when the patient wears a device

  3. Time between alarm (continuous data) and next regular MEWS measurement (nurse)

    Time frame: during 2-3 days when the patient wears a device

  4. Amount of extra MEWS measurements by nurses due to alarms

    Time frame: during 2-3 days when the patient wears a device

  5. Admission to ICU (yes/no)

    Time frame: during 2-3 days when the patient participates in this study

  6. Duration of ICU hospitalization in days

    Time frame: during 2-3 days when the patient participates in this study

  7. Complications caused by disease or surgical procedure

    Time frame: during 2-3 days when the patient participates in this study

  8. Adverse events caused by devices

    Time frame: during 2-3 days when the patient wears a device

    E.g. Itch or redness

  9. Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)

    Time frame: during 2-3 days when the patient wears a device

  10. Outcomes of the State Trait Anxiety Inventory (STAI)

    Time frame: Once a day during the 2-3 days the patient participantes in this study

  11. Outcomes of the Pain Catastrophizing Scale (PCS)

    Time frame: On day 2 or 3 when patients participates in the study

  12. System usability Scale

    Time frame: 1 year

Other outcomes

  1. Gender

    Time frame: On day 1 when patients participates in the study

    Extraction from EHR

  2. Age

    Time frame: On day 1 when patients participates in the study

    Extraction from EHR

  3. Diagnosis

    Time frame: On day 1 when patients participates in the study

    Extraction from EHR

  4. Performed surgical procedure

    Time frame: On day 1 when patients participates in the study

    Extraction from EHR

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Continuous Monitoring of Vital Signs in Hospitalized Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2016
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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