validation study SpO2 diverse skin types

Validating SpO2 Accuracy Across Diverse Skin Types: The IMPCA Study on viQtor Pulse Oximetry at LUMC

Collaboration with: Leiden University Medical Center (LUMC)

Study Overview
The IMPCA Study is a clinical validation study conducted in the anesthesia department at LUMC. This single-center study evaluates the accuracy of the viQtor pulse oximetry solution in measuring SpO2 levels across different skin types.

Key Participants
36 patients undergoing hypoxic time periods for matched SaO2 and SpO2 measurements.

Primary Objective
The study aims to evaluate the accuracy of SpO2 measurements by viQtor in comparison to matched SaO2 measurements, for different Fitzpatrick skin types (I-VI). Additionally, viQtor's pulse rate and respiratory rate measurements will be evaluated.

Key Results and Benefits
A total of 34 healthy subjects were included, resulting in 2841 SpO2-SaO2 data pairs, which showed an overall ARMS of 1.61% (range of 1.37-1.95% across skin types). This level of accuracy meets FDA requirements for all skin tone categories. It provided reliable SpO2 readings with minimal incidences of occult hypoxemia, particularly in individuals with Fitzpatrick skin types 5-6. For pulse rate, a deviation of 1.61 BPM was observed, and for respiratory rate a deviation of 1.71 BPM. This highlights viQtor's effectiveness and suitability for diverse patient populations, supporting its potential for widespread clinical use.

Study Duration

Start: December 2023

Duration: 3 months

Status: Completed. Publication expected in 2025.