Summary

Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

The goal of this clinical trial is to determine if pulse oximeters show an SaO2-SpO2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The main questions it aims to answer is if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on SaO2-SpO2 discrepancy, and if packed red blood cell (PRBC) transfusion has an influence on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. Researchers will compare SaO2 and SpO2 values in neonates of various skin pigmentation.

Details

Investigators will use a multicenter prospective cohort approach to measure SpO2 and SaO2 simultaneously in newborns of varying degrees of light and dark skin. The investigators will enroll 163 newborns of varying degrees of light and dark skin to assess the impact of skin pigmentation on the accuracy of pulse oximetry. Data collection will occur during routine blood samples and will involve simultaneous measurement of oxygen saturation by pulse oximetry and additional data extraction from the EHR. The study consists of 4 main components: (1) Skin pigment classification (2) Race and ethnicity classification (3) SpO2 measurement collection (4) EMR data collection (including newborn screen hemoglobin type assessment and transfusion records). After adjusting for SaO2, the SaO2-SpO2 discrepancy will correlate with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The distribution of SaO2-SpO2 discrepancy will have more variance in the newborns with darker skin.

Keywords

Skin Pigment, Pulse Oximetry, Pigmentation Disorders, Enrolled Participant

Eligibility

You can join if…

  • Newborns postnatal age < 10 days admitted to intensive care unit
  • Presence of arterial catheter or undergoing arterial stick blood gas sampling

You CAN'T join if...

  • <26 weeks corrected gestational age (After May 2024, infants <26 weeks corrected GA were excluded due to skin irritation with sensor removal, those enrolled earlier were included in the analysis)
  • Presence of abnormal hemoglobin (including methemoglobin > 3%) - likely to only be known after enrolled and the blood gas is obtained
  • Those in whom SpO2 cannot be measured in the same extremity as the arterial catheter.

Locations

  • UC Davis Health
    Sacramento California 95817 United States
  • University of Mississippi Medical Center
    Jackson Mississippi 39216 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06063148
Study Type
Interventional
Participants
Expecting 163 study participants
Last Updated