Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

NCT05617547 | Recruiting FDA Device

• 1 other identifier: SU_IRB_66947
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Conditions

Congenital Heart Disease in Children; Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Saturation by pulse oximetry (Sp02)

  Oxygen saturation as measured by pulse oximetry

  Up to 2 weeks after consent and arterial line placement (where Sp02 will be compared to simultaneous measurements of the Sa02, or oxygen saturation using blood from the artery)

Study Arms (1)

Pulse Oximetry Observational Cohort

Diagnostic Test: Pulse Oximeter (Massimo)

Interventions

Pulse Oximeter (Massimo) DIAGNOSTIC_TEST

The Massimo LNCS (low noise cabled sensors) pulse oximeter will be used to estimate the oxygen saturation and compared to the gold standard, the arterial oxygen saturation in the blood as measured by co-oximetry. The pulse oximeters is FDA cleared for this purpose so patients will not be exposed to any interventions that are not standard of care.

Pulse Oximetry Observational Cohort

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children ≤21 years of age receiving care at Lucile Packard Children's Hospital and who require an arterial vascular access catheter as part of their clinical care will be eligible for inclusion in the study.

You may qualify if:

• Age ≤21 years of age
• Requires arterial vascular access as part of routine clinical care
• Patient or legally authorized representative (LAR) willing to provide written informed consent

You may not qualify if:

• Anemia defined as a Hgb \<8 g/dL
• Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurate
• Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisable
• Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO)
• Lack of informed consent

Sponsors & Collaborators

• Stanford University: lead
• Food and Drug Administration (FDA): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Christopher S Almond, MD, MPH

CONTACT

650-7237913; calmond@stanford.edu

Selena Gonzales, MPH

CONTACT

650-723-7913; selena.gonzales@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: November 15, 2022
• Study Start: August 31, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

US (1)