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Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood SaO2 \<90% when their pulse oximeter reads 92% or greater.
Conditions:
🦠 Hypoxemia 🦠 Pulse Oximetry 🦠 Skin Pigment
🗓️ Study Start (Actual) 14 August 2022
🗓️ Primary Completion (Estimated) 1 October 2024
✅ Study Completion (Estimated) 1 October 2024
👥 Enrollment (Estimated) 800
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18 years of age or older
    • * hospitalized and at high risk of hypoxemia, defined as saturations \< 90%,
    • * patients with arterial line in place for clinical purposes

    Exclusion Criteria:

    • * Profound anemia, defined as hemoglobin \< 8 g/dl will preclude blood draws for research purposes
    • * Known pregnancy
    • * In custody of law enforcement officials
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2022
  • First Submitted that Met QC Criteria 21 September 2022
  • First Posted 26 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024
I'm interested ...!!