NightOwl Pulse Oximeter Calibration Study

Not Applicable

• Conditions: Pulse Oximeter Calibration

• Registration Number: NCT03774199
• Lead Sponsor: Ectosense NV

Brief Summary

Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead.

The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2018-12-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Primary Completion: 2019-12-14
• Study Completion: 2020-04-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)

Exclusion Criteria

• smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels.
• individuals subject to conditions that result in elevated levels of methaemoglobin.
• individuals with arterial cannulation or hypoxia at FiO2 = 0,21

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
A_rms determination	Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.	After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.

Trial Locations

Locations (1)

CMC; 🇧🇪 Genk, Limburg, Belgium