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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
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Colorectal Neoplasms Arthritis Hypertension Sepsis Device: HealthPatch Device: ViSi Mobile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Harry van Goor, MD, PhD, FRCS Radboud UMC

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02933307    
Other Study ID Numbers: HEEL-2015-03
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinoma, Pancreatic Ductal
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases