Continuous Monitoring on the General Ward

April 24, 2017 updated by: Radboud University Medical Center

Continuous Monitoring of Vital Signs in Hospitalized Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
Experimental: HealthPatch (Intervention)
Patients with HealthPatch and regular MEWS measurements
Device: HealthPatch
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
Experimental: ViSi Mobile (Intervention)
Patients with ViSi Mobile and regular MEWS measurements
Device: ViSi Mobile
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2-3 days after informed consent
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEWS scores based on continuous data and data measured by nurses
Time Frame: 3 times a day, up to three days.
3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
Time Frame: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Time Frame: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
Time Frame: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
Time Frame: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
Time Frame: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
Time Frame: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Adverse events caused by devices
Time Frame: during 2-3 days when the patient wears a device
E.g. Itch or redness
during 2-3 days when the patient wears a device
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
during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
Time Frame: Once a day during the 2-3 days the patient participantes in this study
Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
Time Frame: On day 2 or 3 when patients participates in the study
On day 2 or 3 when patients participates in the study
System usability Scale
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Age
Time Frame: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Diagnosis
Time Frame: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Performed surgical procedure
Time Frame: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEEL-2015-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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