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NCT02237014 · ClinicalTrials.gov registry record

Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

A clinical trial, sponsored by Stanford University.

Completed
Registry status
53
Enrollment target

NCT02237014: Completed study, sponsored by Stanford University.

NCT02237014 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02237014 has completed, sponsored by Stanford University.

COMPLETED
Registry status
53 participants
Enrollment target

Study Summary

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

Primary Outcome

The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2012-11
Est. Completion 2014-12
Stanford University

1,744 total trials

What the finished NCT02237014 record still lists

NCT02237014 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02237014 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02237014 about?

NCT02237014 is a clinical study titled "Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease". Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a ...

What is the current status of trial NCT02237014?

This trial is currently completed. The enrollment target is 53 participants. The study started on 2012-11. Estimated completion is 2014-12.

Who is sponsoring clinical trial NCT02237014?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02237014, the US trial registry maintained by the National Library of Medicine. NCT02237014 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.