Continuous Monitoring on the General Ward
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|ClinicalTrials.gov Identifier: NCT02933307|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : April 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Pancreatic Ductal Colorectal Neoplasms Arthritis Hypertension Sepsis||Device: HealthPatch Device: ViSi Mobile||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Monitoring of Vital Signs in Hospitalized Patients|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
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
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.
- 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
- 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
- MEWS scores based on continuous data and data measured by nurses [ Time Frame: 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 ]
- Time between alarm (continuous data) and next regular MEWS measurement (nurse) [ Time Frame: 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 ]
- Admission to ICU (yes/no) [ Time Frame: 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 ]
- Complications caused by disease or surgical procedure [ Time Frame: 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
- 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 ]
- Outcomes of the State Trait Anxiety Inventory (STAI) [ Time Frame: 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 ]
- System usability Scale [ Time Frame: 1 year ]
- Gender [ Time Frame: On day 1 when patients participates in the study ]Extraction from EHR
- Age [ Time Frame: On day 1 when patients participates in the study ]Extraction from EHR
- Diagnosis [ Time Frame: On day 1 when patients participates in the study ]Extraction from EHR
- Performed surgical procedure [ Time Frame: On day 1 when patients participates in the study ]Extraction from EHR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933307
|Principal Investigator:||Harry van Goor, MD, PhD, FRCS||Radboud UMC|