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Clinical trialNCT02237014CompletedObservational

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

SponsorStanford UniversityEnrollment53Cyanotic Heart Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Chandra Ramamoorthy, MD

    Department of Anesthesia, Stanford University School of Medicine

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Stanford University Medical Center

    Stanford, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2012
Primary completion
31 Dec 2014
Completion
31 Dec 2014
Last update posted
8 Mar 2017
Registered enrollment
53
Registry id
NCT02237014

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.