NightOwl Pulse Oximeter Calibration Study

Pulse Oximeter Calibration Clinical Trial

— NPOCS  

Official title:

NightOwl Pulse Oximeter Calibration Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774199
• Other study ID #: 17-023U1.1
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: April 14, 2020

Study information

• Verified date: March 2019
• Source: Ectosense NV
• Contact: Frederik Roger Massie, ir
• Phone: 474942710
• Email: frederik.massie[@]ectosense.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 14, 2020
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulse Oximeter Calibration

Intervention

Device:
• NightOwl
The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived

Locations

Country	Name	City	State
Belgium	CMC	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ectosense NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A_rms determination	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.	Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.