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NCT03435211 · ClinicalTrials.gov registry record

Desaturation Validation of INVSENSOR00006

A clinical trial, sponsored by Masimo Corporation.

Completed
Registry status
52
Enrollment target

NCT03435211: Completed study, sponsored by Masimo Corporation.

NCT03435211 is a clinical trial that has completed, run by Masimo Corporation. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03435211 has completed, sponsored by Masimo Corporation.

COMPLETED
Registry status
52 participants
Enrollment target

Study Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. The subject will then be returned to inhaling room air.

Primary Outcome

Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value.

Interventions

  • DEVICE INVSENSOR00006

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2018-01-17
Est. Completion 2018-02-19
Masimo Corporation

96 total trials

What the finished NCT03435211 record still lists

NCT03435211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00006 is the first listed.

NCT03435211 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03435211 about?

NCT03435211 is a clinical study titled "Desaturation Validation of INVSENSOR00006". This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concen...

What is the current status of trial NCT03435211?

This trial is currently completed. The enrollment target is 52 participants. The study started on 2018-01-17. Estimated completion is 2018-02-19.

What interventions are being tested in trial NCT03435211?

The interventions under investigation include: INVSENSOR00006 (DEVICE).

Who is sponsoring clinical trial NCT03435211?

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

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Source: ClinicalTrials.gov NCT03435211, the US trial registry maintained by the National Library of Medicine. NCT03435211 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.