NCT03774199

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

December 10, 2018

Last Update Submit

March 19, 2019

Conditions

Pulse Oximeter Calibration

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Pulse oximeter calibration population

OTHER
Device: NightOwl

Interventions

NightOwlDEVICE

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

Pulse oximeter calibration population

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC

Genk, Limburg, 3600, Belgium

RECRUITING

Central Study Contacts

Frederik Roger Massie, ir

CONTACT

474942710frederik.massie@ectosense.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

December 14, 2018

Primary Completion

December 14, 2019

Study Completion

April 14, 2020

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)