NightOwl Pulse Oximeter Calibration Study (NPOCS)

Ectosense

Status: Unknown

Conditions: Pulse Oximeter Calibration

Treatments: Device: NightOwl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03774199

17-023U1.1

Details and patient eligibility

About

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)

Enrollment: 30 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Pulse oximeter calibration population

Other group

Treatment:

Device: NightOwl