Vitaliti Continuous Vital Signs Monitor User-Testing Protocol: VERDICT-2

Hamilton Health Sciences (HHS)

Status: Not yet enrolling

Conditions: Surgery

Treatments: Other: User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06464094

3.0_2023.05.31

Details and patient eligibility

About

The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.

Full description

Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved.

The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography [PPG]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques.

The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.

Enrollment: 45 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria

1. Age ≥45 years; 2) Undergoing inpatient non-cardiac surgery with general or regional anesthesia; 3) Expected to spend at least two nights in hospital after surgery; 4) Provide written informed consent to participate in the VERDICT-2 Study, AND 5) Fulfill ≥ 1 of the following criteria (a-e):

a. History of coronary heart disease; b. History of stroke; c. History of peripheral arterial disease; d. Preoperative NT-proBNP value ≥200 ng/L e. OR fulfill ≥3 of the following 9 risk factors: i) Undergoing major surgery ii) Undergoing urgent or emergent surgery iii) History of hypertension iv) History of congestive heart failure v) History of transient ischemic attack vi) History of smoking within 2 years of surgery vii) Diabetes and currently taking an oral hypoglycemic agent or insulin viii) Age >70 years

Patient Exclusion Criteria

1. Intolerance/allergy to adhesive
2. Hearing aid/Cochlear Implant
3. Patients with cognitive or physical impairments hindering understanding the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology will not be eligible for recruitment

Family/Care Giver Inclusion Criteria:

1. Age >18 years
2. Family or non-family member, residing in the same household as the patient or closely involved in the patient's postoperative recovery
3. Provide written informed consent to participate in the VERDICT-2 Study

Family/Care Giver Exclusion Criteria:

1. Caregivers with cognitive or physical impairments hindering understanding the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology will not be eligible for recruitment

Clinician Inclusion Criteria:

1. Registered Nurse or Physician engaged in perioperative care
2. Employed at Hamilton Health Sciences
3. Provide written informed consent to participate in the VERDICT-2 Study

Clinician Exclusion Criteria:

1. Clinicians unable to understand the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology due to language barriers will not be eligible for recruitment
2. Non-practicing class of licensure

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Other group

Description:

Participants enrolled to engage in user-testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A to examine user-acceptance and user experiences, while soliciting user feedback on wearability compliance (patient) and proposed clinical workflows using the most recent Vitaliti™ CVSM device.

Treatment:

Other: User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A