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

NCT02237014 | Completed

• 1 other identifier: SU-11062012-11219
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cyanotic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease

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

  2 year

Secondary Outcomes (1)

• establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

  2year

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cyanotic heart disease undergoing cardiac catheterization or heart surgery in Stanford University Medical Center(SUMC) or Lucile Packard Children's Hospital(LPCH) respectively with peripheral arterial saturation less than 90% at time of enrollment.

You may qualify if:

• Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH respectively
• Peripheral arterial saturation less than or equal to 90% at time of enrollment
• weigh between 3-20 kg
• Less than or equal to 10 years of age

You may not qualify if:

• Lack of consent
• Greater than 10 years of age
• Less than 3 kg or more than 20 kg in weight
• Peripheral arterial saturation greater than 90% at time of enrollment
• Lack of arterial access

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (3)

• Cox P: New pulse oximetry sensors with low saturation accuracy claims-a clinical evaluation [Internet]. Anesthesiology 2007; 107:A1540

  BACKGROUND

• Ross PA, Newth CJ, Khemani RG. Accuracy of pulse oximetry in children. Pediatrics. 2014 Jan;133(1):22-9. doi: 10.1542/peds.2013-1760. Epub 2013 Dec 16.

  PMID: 24344108 BACKGROUND

• Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatr Crit Care Med. 2016 Apr;17(4):315-20. doi: 10.1097/PCC.0000000000000660.

  PMID: 26914626 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

Study Officials

• Chandra Ramamoorthy, MD

  Department of Anesthesia, Stanford University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatric Cardiac Anesthesia

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: September 11, 2014
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)