Postoperative patients with various conditions, including COPD, undergoing different surgical procedures such as cardiac ablation. These patients exhibit diversity in vital sign parameters, partly due to an increased risk of cardiac arrhythmias and decreases in oxygen saturation.
Conditions
Interventions
In this study, two viQtor devices are used: a derived research device (SQ-RD) based on the currently CE-certified viQtor device (viQtor 1), and the viQtor 2. The viQtor 2 is equipped with the new soft
Sponsors
smartQare BV
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Adult (age 18+) - equal mix regarding gender and age - Post-operative connection to patient monitors - No cognitive impairments - Hospitalized because of moderate/major surgery - Fluent in the Dutch language - Willing and able to sign informed consent
Exclusion criteria
Exclusion criteria: - Patients with known extremely sensitive skin, or allergies to metal or plastics. - Patients with significant upper arm deformities, swelling, irritation, injuries, degenerative changes, infectious diseases, or oedema at the moment of inclusion - cuff, or IV line). - Patients with tremors or convulsions (e.g. Parkinson). - Patients with tattoos on the upper arm where the device*s PPG sensor will be placed. - Patients with upper arm sizes outside the wearable*s fitting range. - Emergency (surgical) patients, as obtaining true informed consent may not be feasible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the accuracy of viQtor RR by comparing it with the RR data obtained through the ECG measurement from the reference device: Spacelab type XPREZZON® 91393 and in phase 2 also from real-time CO2 waveforms collected with the Smart Advanced CapnoLine® H Plus EtCO2 sampling line (Medtronic, Boulder, CO, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the accuracy of viQtor SpO2 by comparing it with SpO2 from a reference device (Spacelab type XPREZZON ® 91393).Determine accuracy of the viQtor PR by comparing it with ECG-based heart rate from a reference device (Spacelab type XPREZZON ® 91393).Other secondary objectives are:Evaluate the user acceptability of the viQtor device with a short questionnaire. This questionnaire, comprising three questions, using a 5-point Likert scale ranging from ‘strongly agree’ to ‘strongly disagree.’ These questions specifically address user perspectives on comfort and recommendations for future use of the viQtor device.Evaluate the number and type of artefacts of the algorithms.Evaluate the longitudinal data coverage per patient with the viQtor solution in the hospital setting. | — |
Countries
Netherlands
Contacts
Public ContactEEC Waal
Universitair Medisch Centrum Utrecht
Outcome results
None listed