Exploring Pulse Oximeter Accuracy Across Skin Tones | ICNARC Study

www.icnarc.org Exploring Pulse OXimeter Accuracy Across SKin Tones Chief Investigators: Professor Daniel Martin & Mr Paul Mouncey Training Session @UKRoxTrial EXAKT Training Session 1

Agenda Background Governance Delivery of EXAKT Support/resources www.icnarc.org EXAKT Training Session 2

Agenda Background Governance Delivery of EXAKT Support/resources www.icnarc.org EXAKT Training Session 3

Background Pulse oximeters are a non-invasive device that determine peripheral arterial oxygen saturation (SpO2), an estimation of true arterial oxygen saturation (SaO2) measured by an arterial blood gas (ABG) machine. www.icnarc.org The quality of the light signal transmitted during pulse oximetry can be affected by several patient-related factors, resulting in inaccurate SpO2estimations. Skin tone is known to be one of these factors. EXAKT Training Session 4

Background An increasing number of studies have shown that for people with darker (pigmented) skin tones, pulse oximeters may over- estimate their true oxygen level. www.icnarc.org Analysis of data from previously published studies found that in Black patients, SpO2was consistently 3-5% higher than SaO2. Other studies testing several models of pulse oximeters concluded that in people with pigmented skin tones, SpO2is over-estimated during hypoxaemia. EXAKT Training Session 5

Background Black patients had nearly three times the frequency of occult hypoxemia (SaO2of <88% when a paired SpO2reading was 92-96%) that was not detected by pulse oximetry as White patients. www.icnarc.org Sjoding, MW et al. Racial Bias in Pulse Oximetry Measurement. The New England Journal of Medicine 2020 EXAKT Training Session 6

Background Safe and effective care of patients with low oxygen levels relies on accurate measurement of SpO2with a pulse oximeter. www.icnarc.org Significant potential to under-treat people with pigmented skin if pulse oximeters over-estimate true SaO2. Aim: To determine the impact of skin tone on the diagnostic accuracy of fingertip pulse oximeters in adult patients. EXAKT Training Session 7

Sub-study design Multi-centre, diagnostic accuracy, Study Within a Trial (SWAT) embedded in UK-ROX www.icnarc.org 900 patients o Recruited from approx. 24 ICUs o 12-month recruitment period We are working closely with community engagement groups during the course of the study EXAKT Training Session 8

Outcomes Primary o Accuracy of SpO2measurement, validated against co-oximeter derived SaO2ABG analysis (calculated as SpO2minus paired SaO2). www.icnarc.org Secondary o Diagnostic accuracy (area under the receiver operating characteristic curve and sensitivity and specificity at relevant cut- points) for SpO2as a predictor of SaO2 92%. o Occult hypoxaemia (SaO2< 88% among participants with a paired SpO2reading of 92- 96%). EXAKT Training Session 9

Agenda Background and trial design Governance Delivery of EXAKT Support/resources www.icnarc.org EXAKT Training Session 10

Central governance Funded by NIHR Health Technology Assessment Programme HRA/HCRW Approval and REC favourable ethical opinion in place for substantial amendment 4 Separate accruals available for EXAKT study recruitment www.icnarc.org Oversight by: o EXAKT Trial Management Group o UK-ROX Trial Committees EXAKT Training Session 11

Local governance Nominated Equality, Diversity, and Inclusivity (EDI) advocate o Interested in EDI and champion of the sub-study o Fully trained in the use of the spectrophotometer and can train others to use it o Focused on driving recruitment for the sub-study o Spread awareness about the sub-study on the unit www.icnarc.org Oversight by UK-ROX site level Principal Investigator UK-ROX and EXAKT ISF documents provided electronically EXAKT Training Session 12

Agenda Background and trial design Governance Delivery of EXAKT Support/resources www.icnarc.org EXAKT Training Session 13

Eligibility Mechanically ventilated adult participants (aged 18 years) from two distinct groups, outlined below: www.icnarc.org i. ii. Patients screened for but not included in the UK-ROX trial (e.g., patients falling outside of the 12-hour recruitment window, the UK- ROX intervention is deemed indicated or contraindicated or there is a clinical reason not to randomise the patient). Patients enrolled into the UK-ROX trial, Screen all patients receiving invasive mechanical ventilation in ICU Co-enrolment will be permitted with all studies without prior agreement needed EXAKT Training Session 14

Eligibility FAQs answered Only include patients into EXAKT that you usually screen for UK- ROX i.e., patient meeting the inclusion criteria of receiving MV following an unplanned admission. www.icnarc.org Elective surgery patients are not eligible as they are not usually screened for UK-ROX. The observation period should continue even if the patient is extubated during the 24-hour period. EXAKT Training Session 15

See SOP 004 and 013 Enrolment Patients randomised into UK-ROX New question at randomisation: Ethnicity White or Non-white Outcome of enrolment into EXAKT provided by randomisation service www.icnarc.org Patients screened and not randomised into UK-ROX Consent/ opinion must be sought prior to enrolment into EXAKT Eligibility for EXAKT should be assessed based on the patient s ethnicity If patient/ consultee agree to participate, EXAKT Trial Number is allocated from a Trial Number list provided by ICNARC Recorded on UK-ROX Screening Log EXAKT Training Session 16

See SOP 003 UK-ROX Screening and Enrolment Log Screening Log o Section D added for EXAKT patients Complete Section D for all patients o Ethnicity (White/Non-White) o Enrolled into EXAKT? (Y/N) o If enrolled, record Trial Number 17

Pulse oximetry-derived SpO2measurement Each participating site randomly allocated two pulse oximeters o Labelled e.g. A, B, C, D, E o ICU pulse oximeter must be used to guide care www.icnarc.org Following enrolment, two pulse oximeters under evaluation placed onto patient's fingers, on the same hand 24-hour observation period commences (or until discharge, withdrawal/ refusal of consent/opinion) EXAKT Training Session 18

Arterial oxygen saturation (SaO2) www.icnarc.org Arterial blood gases (ABG) taken only when clinically indicated as per routine care When the ABG is taken, the corresponding fingertip pulse oximeter SpO2values should be recorded onto the paper CRF Continue until the end of the 24-hour period EXAKT Training Session 19

Skin tone assessment www.icnarc.org Taken using the Konica Minolta CM-600d spectrophotometer (a battery-operated, hand-held device designed to accurately measure colour), provided by ICNARC The spectrophotometer can be used at any timepoint following enrolment into EXAKT, and prior to critical care unit discharge, to measure the patient s skin tone. Site staff must be trained in the use of the spectrophotometer prior to use, recorded on the EXAKT Training Log. EXAKT Training Session 20

Data collection and entry Patients added to UK-ROX MACRO database o Different forms will open depending on whether the patient is in UK- ROX only, UK-ROX and EXAKT, or EXAKT only www.icnarc.org Additional measurements for EXAKT: o Arterial blood gas measurements: SaO2, and if available: Hb, CO-Hb, Met-Hb, F-Hb o Corresponding SpO2from pulse oximeters under evaluation o Skin tone measurements taken from four separate areas using spectrophotometer Data must be recorded on EXAKT paper CRFs, and entered onto the database once consent/ opinion is in place EXAKT Training Session 21

Lower oxygen saturations UK-ROX/EXAKT patients Take paired measurements once the patient is within the UK-ROX conversative target range (88-92%) (only applicable to conservative arm patients) Assess on an individual basis aim to take paired measurements when SpO2 <96% www.icnarc.org EXAKT-only patients Obtain readings during periods of lower oxygen saturations (SpO2 <96%) for this group of patients. EXAKT Training Session 22

www.icnarc.org Any questions? EXAKT Training Session 23

See SOP 007 Consent procedures Patients randomised into UK-ROX Consent procedures will be carried out as per UK-ROX Research without prior consent www.icnarc.org Patients screened and not randomised into UK-ROX Agreement must be sought prior to enrolment into EXAKT Role of Personal/ Nominated Consultee the same as UK-ROX Refusals/ withdrawals treated the same EXAKT Training Session 24

See SOP 007 Consent procedures UK-ROX and EXAKT patients Approach patient for consent Once medical situation is no longer an emergency (around 24-48 hours after randomisation) Patient confirmed eligible Approach Personal Consultee for opinion (in person/telephone) If patient lacks capacity Randomisation Seek verbal/ other non-written consent, if appropriate Approach Nominated Consultee for opinion 25

See SOP 013 Consent procedures EXAKT only patients Agreement in place Patient regains capacity Patient confirmed eligible Approach patient for consent Enrolled into EXAKT Approach Personal Consultee for opinion (in person/telephone) Seek verbal/ other non-written consent from patient if appropriate If no personal consultee is available Approach Nominated Consultee for opinion 26

See SOP 013 Consent procedures - documents www.icnarc.org EXAKT Training Session 27

Agenda Background Governance Delivery of EXAKT Support/resources www.icnarc.org EXAKT Training Session 28

Local resources Direct research costs from ICNARC o Per eligible EXAKT patient enrolled: 50 www.icnarc.org Each invoice must quote a unique PO number, requested in advance from uk-rox@icnarc.org Adopted on NIHR Portfolio (46926), separate accruals to UK-ROX EXAKT Training Session 29

Prior to site activation We need from you: o Local confirmation of capacity and capability SA004 o Signed Clinical Trial Site Agreement Schedule 6 o EXAKT Spectrophotometer Training Log o Confirm screening start date www.icnarc.org You need from us: o Spectrophotometer for skin tone assessments o Pulse oximeters for evaluation EXAKT Training Session 30

Lead Investigators Daniel Martin (Chief Investigator) Paul Mouncey (Chief Investigator) Roger Garrett (Patient representative) Catherine Mbeme (Director of Public Health in Lewisham) Eugene Healy (Professor of Dermatology) Segun Olusanya (Consultant) Doug Gould (Senior Researcher) David Harrison (Head Statistician) Kathy Rowan (CTU Director) ICNARC CTU team Tasnin Shahid (Trial Manager) Alvin Richards-Belle (Trial Manager) Amelia Francis Johnson (Research Assistant) Lamprini Lampro (Data Manager) James Doidge (Trial Statistician) Doug Gould (Senior Researcher) Paul Mouncey (Head of Research) www.icnarc.org uk-rox@icnarc.org 020 7269 9277 icnarc.org/Our-Research/ Studies/EXAKT EXAKT Training Session 31

Thank you Any questions? www.icnarc.org EXAKT Training Session 32