elective surgery (cardiothoracic major oncological or major gastro-intestinal) elective surgeries
Conditions
Interventions
The viQtor research device will be used in this study.
Sponsors
PRESSURE consortium
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet the following criteria: - must be 18 years or older. - must be admitted to the ICU at the Catharina Hospital Eindhoven postoperatively. - must have a clinical indication for continuous BP measurement with an arterial line. - must be willing and able to provide informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from this study: - Patients with known extremely sensitive skin or allergies to metal or plastics. - Patients with significant deformities, swelling, irritation, injuries, degenerative changes, infectious diseases, or edema on the upper arm where the device's PPG sensor will be placed. If these conditions affect only one arm, it is recommended to wear the device on the healthy arm. - Patients with tremors and/or convulsions (e.g. Parkinson). - Patients with tattoos on the upper arms where the device's PPG sensor will be placed. If tattoos are present on only one arm, wearing the device on the arm without tattoos is recommended. - 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 |
|---|---|
| The primary endpoint of the study is the technical performance verification of a PPG-based algorithm for continuous one-minute SBP and DBP values derived from viQtor data, meeting standards set by the Association for the Advancement of Medical Instrumentation (AAMI). This is deemed acceptable for clinical purposes if the mean absolute error (MAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.1.2 Secondary study parameters/endpoints • Evaluate whether viQtor*s BP data adheres to at least Grade B of the BHS standard. o For clinical acceptability (minimum Grade B), the MEA and distribution of the MAE between simultaneously paired measurements of both DBP and SBP between the viQtor SQ-RD and the arterial line adhere to the following criteria. Additionally, it is essential that at least 20% of these one-minute median BP measurements obtained by the viQtor SQ-RD are available: * | — |
Countries
Netherlands
Contacts
Public ContactL.L. Giele
Catharina Ziekenhuis
Outcome results
None listed