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NightOwl Pulse Oximeter Calibration Study (NPOCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774199
Recruitment Status : Unknown
Verified March 2019 by Ectosense NV.
Recruitment status was:  Recruiting
First Posted : December 12, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ectosense NV

Study Description
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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)


Condition or disease Intervention/treatment Phase
Pulse Oximeter Calibration Device: NightOwl Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: NightOwl Pulse Oximeter Calibration Study
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : December 14, 2019
Estimated Study Completion Date : April 14, 2020
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. A_rms determination [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774199


Contacts
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Contact: Frederik Roger Massie, ir 474942710 ext +32 frederik.massie@ectosense.com

Locations
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Belgium
CMC Recruiting
Genk, Limburg, Belgium, 3600
Contact: Rafael De Jongh, MD PhD         
Sponsors and Collaborators
Ectosense NV
More Information
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Responsible Party: Ectosense NV
ClinicalTrials.gov Identifier: NCT03774199    
Other Study ID Numbers: 17-023U1.1
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No