Continuous Monitoring on the General Ward

Hypertension Clinical Trial

Official title:

Continuous Monitoring of Vital Signs in Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933307
• Other study ID #: HEEL-2015-03
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: April 24, 2017
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	Extraction from EHR	On day 1 when patients participates in the study
Other	Age	Extraction from EHR	On day 1 when patients participates in the study
Other	Diagnosis	Extraction from EHR	On day 1 when patients participates in the study
Other	Performed surgical procedure	Extraction from EHR	On day 1 when patients participates in the study
Primary	Expectations & experiences of patients	Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group	2-3 days after informed consent
Primary	Expectations & experiences of care givers	Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses	1 year
Secondary	MEWS scores based on continuous data and data measured by nurses		3 times a day, up to three days.
Secondary	Amount of alarms by HealthPatch or ViSi Mobile		during 2-3 days when the patient wears a device
Secondary	Time between alarm (continuous data) and next regular MEWS measurement (nurse)		during 2-3 days when the patient wears a device
Secondary	Amount of extra MEWS measurements by nurses due to alarms		during 2-3 days when the patient wears a device
Secondary	Admission to ICU (yes/no)		during 2-3 days when the patient participates in this study
Secondary	Duration of ICU hospitalization in days		during 2-3 days when the patient participates in this study
Secondary	Complications caused by disease or surgical procedure		during 2-3 days when the patient participates in this study
Secondary	Adverse events caused by devices	E.g. Itch or redness	during 2-3 days when the patient wears a device
Secondary	Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)		during 2-3 days when the patient wears a device
Secondary	Outcomes of the State Trait Anxiety Inventory (STAI)		Once a day during the 2-3 days the patient participantes in this study
Secondary	Outcomes of the Pain Catastrophizing Scale (PCS)		On day 2 or 3 when patients participates in the study
Secondary	System usability Scale		1 year