Continuous Monitoring on the General Ward

NCT ID: NCT02933307

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-09-30

Brief 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.

Conditions

Carcinoma, Pancreatic Ductal; Colorectal Neoplasms; Arthritis; Hypertension; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))

Group Type: NO_INTERVENTION

No interventions assigned to this group

HealthPatch (Intervention)

Patients with HealthPatch and regular MEWS measurements

Group Type: EXPERIMENTAL

HealthPatch

Intervention Type: 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 (Intervention)

Patients with ViSi Mobile and regular MEWS measurements

Group Type: EXPERIMENTAL

ViSi Mobile

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry van Goor, MD, PhD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

References

Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471.

Reference Type: DERIVED

PMID: 32519972 (View on PubMed)

Other Identifiers

HEEL-2015-03

Identifier Type: -

Identifier Source: org_study_id