NightOwl Pulse Oximeter Calibration Study (NPOCS)

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)

Study Overview

• Status: Unknown
• Conditions: Pulse Oximeter Calibration
• Intervention / Treatment: Device: NightOwl

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • CMC
      • Contact: Rafael De Jongh, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pulse oximeter calibration population	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Ectosense NV

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Anticipated): December 14, 2019
• Study Completion (Anticipated): April 14, 2020

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17-023U1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No