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 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.

Study Overview

• Status: Completed
• Conditions: Cyanotic Heart Disease

Detailed Description

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 we will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

The investigator hopes to learn the limits of accuracy of currently available and used pulse oximeters. In children with cyanotic heart disease the "blue sensor" has been found in small studies to be more accurate compared to the "standard" pulse oximeter.

This study is important as it will provide information as to which pulse oximeter should be routinely used in children with cyanotic heart disease and to assess which SPO2 even with blue sensor is borderline and therefore the physician will know to obtain arterial blood sample for co-oximeter prior to planning important procedures based on a saturation reading.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.	The secondary measure was to describe the limits of the blue sensor and standard sensor accuracy as compared with the co-oximeter. If the test sensors consistently have a bias greater than 2 SD from the co-oximeter value at saturations lower than eg., 80 then the recommendation would be that the co-oximetry be used to measure patients saturatioin rather than relying on pulse oximtery alone for clinical decision making	2year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Chandra Ramamoorthy, MD, Department of Anesthesia, Stanford University School of Medicine

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: SU-11062012-11219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES