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OpenTrials
Completed

NCT Number: NCT04584788

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

Completed

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Key information

Conditions

Oxygen Deficiency Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 45 years, inclusive
  • Willing and able to provide written informed consent
  • Healthy subjects

Exclusion criteria

  • Pregnant women
  • Presence of any cardiovascular or pulmonary disease
  • Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
  • Known allergy to intravenous contrast medium or heparin
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
  • Patients deemed not suitable for the study at the discretion of the Investigator

Treatment and study plan

Masimo O3 Regional Oximeter

Device

Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

Primary outcomes

  1. Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2

    Time frame: 1 visit up to 8 hours

    Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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