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NCT03488238 · ClinicalTrials.gov registry record

Correlation of Changes in PaO2 and ORi in Adult Patients

A clinical trial, sponsored by Masimo Corporation.

Completed
Registry status
31
Enrollment target

NCT03488238: Completed study, sponsored by Masimo Corporation.

NCT03488238 is a clinical trial that has completed, run by Masimo Corporation. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03488238 has completed, sponsored by Masimo Corporation.

COMPLETED
Registry status
31 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DEVICE ORi sensor

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2018-08-01
Est. Completion 2018-09-19
Masimo Corporation

96 total trials

What the finished NCT03488238 record still lists

NCT03488238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which ORi sensor is the first listed.

NCT03488238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03488238 about?

NCT03488238 is a clinical study titled "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...

What is the current status of trial NCT03488238?

This trial is currently completed. The enrollment target is 31 participants. The study started on 2018-08-01. Estimated completion is 2018-09-19.

What interventions are being tested in trial NCT03488238?

The interventions under investigation include: ORi sensor (DEVICE).

Who is sponsoring clinical trial NCT03488238?

This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03488238, the US trial registry maintained by the National Library of Medicine. NCT03488238 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.