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Exploring Pulse OXimeter Accuracy Across SKin Tones

NCT05481515 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 903

Last updated 2025-03-12

No results posted yet for this study

Summary

This study within a trial (SWAT) will be a sub-study of the UK-ROX trial (ISRCTN13384956), which is currently running in intensive care units across the UK. UK-ROX is large-scale randomised controlled trial evaluating conservative oxygen therapy (a target SpO2 of 88-92%) versus usual oxygen therapy in mechanically ventilated adult patients admitted to ICUs in the UK. The purpose of this observational sub-study is to compare pulse oximeter-derived peripheral oxygen saturation (SpO2) values to co-oximeter-derived arterial oxygen saturation (SaO2) measurements from arterial blood gas (ABG) samples, for a range of fingertip pulse oximeters in an ethnically diverse group of adult patients admitted to UK intensive care units (ICUs). Approximately 900 patients will be recruited over 12 month period from 24 sites to provide an anticipated 10,800 paired SpO2 and SaO2 measurements. Patient skin tone will be objectively measured using a handheld spectrophotometer. Data from the sub-study will be used to determine the accuracy of the tested pulse oximeters across a range of skin tones and arterial oxygenation levels.

Conditions

  • Critical Illness
  • Hypoxemia

Interventions

DEVICE

Pulse oximetry

Pulse oximeters will be evaluated against routine arterial blood gas measurements

DEVICE

Spectrophotometry

Spectrophotometry will be used to measure skin tone

Sponsors & Collaborators

  • Lewisham Council

    collaborator UNKNOWN

  • Centre Ethnic Health Research

    collaborator UNKNOWN

  • Intensive Care National Audit & Research Centre

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2024-08-15
Completion
2024-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481515 on ClinicalTrials.gov