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OpenTrials
Completed

NCT Number: NCT03488238

Correlation of Changes in PaO2 and ORi in Adult Patients

The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.

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Key information

Conditions

Hyperoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

UC Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than 18 years
  • ASA physical status III or IV
  • Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia

Exclusion criteria

  • Age less than 18 years
  • Adults unable to give primary consent
  • Pregnancy
  • Prisoners

Treatment and study plan

ORi sensor

Device

Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi

Primary outcomes

  1. Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

    Time frame: Less than 30 mins

    ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.

  2. Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

    Time frame: Less than 30 mins

    ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.

  3. Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

    Time frame: Less than 30 minutes

    ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2018
Registry last updated
Sep 20, 2021

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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