Oximeter Comparison for Low Oxygen Levels

(Oxygap 2 Trial)

Recruiting at 5 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Vasopressors, Inotropes

Disqualifiers: Pigmented nails, Methemoglobinemia, Hemoglobin below 80, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different pulse oximeters measure blood oxygen levels in Intensive Care Unit (ICU) patients. These devices help doctors ensure patients receive the right amount of oxygen, avoiding hypoxemia or hyperoxia. The trial will evaluate several oximeter brands for accuracy compared to a direct blood test. It is suitable for adults in the ICU who already have an artery catheter in place. This research could improve guidelines for oxygen therapy, ensuring safer patient care. As an unphased trial, it offers participants the chance to contribute to enhancing medical devices for safer oxygen therapy in critical care settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these oximeters are safe for monitoring oxygen therapy?

Research has shown differences between SpO2 (oxygen level measured by a device) and SaO2 (oxygen level measured directly from blood). One study found that SpO2 readings were often higher than SaO2, indicating that devices might sometimes overestimate blood oxygen levels. Another study discovered that while SpO2 and SaO2 measurements usually change together, they don't always match perfectly.

These studies suggest that while oximeters (devices that measure SpO2) are generally safe, they can sometimes be inaccurate. This is crucial for ensuring safe oxygen therapy. However, no reports of serious safety issues with these devices exist. They are approved and used in hospitals worldwide, indicating their safety for measuring oxygen levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare the accuracy of pulse oximeters against arterial saturation measurements in both adults and children. Unlike current devices, which can sometimes give inaccurate readings under certain conditions like low blood flow or skin pigmentation variations, this study hopes to identify which oximeters provide the most reliable data. The outcome could lead to more precise monitoring of patients' oxygen levels, ultimately improving patient care and safety.

What evidence suggests that this trial's oximeter comparisons could be effective for monitoring oxygen levels?

This trial will compare the accuracy of pulse oximeters (SpO2) with direct blood tests (SaO2) in both adult and pediatric populations. Research has shown that pulse oximeters, which measure blood oxygen levels, are generally accurate when levels exceed 90%. However, some studies have identified discrepancies between pulse oximeter readings and direct blood test results. For instance, one study found that pulse oximeter readings were slightly lower than direct blood test results. Accuracy may vary among different oximeter brands. Understanding these differences is crucial for developing better guidelines for oxygen therapy and ensuring patient safety by preventing dangerously low or high oxygen levels. ^{6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

You are part of the adult population.

Individuals admitted to the Intensive Care Unit.

An artery catheter is already installed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Comparison of SpO2 values from different oximeters with SaO2 reference value obtained by arterial gas

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SpO2 and SaO2 comparison

How Is the Trial Designed?

Group I: Pediatric population Experimental Treatment 1 Intervention

Pediatric population \< 18 years old (estimated 100 patients)

Group II: Adult population Experimental Treatment 1 Intervention

Adult population \>or= 18 years old (estimated 100 patients)

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449267/

Comparative Analysis of Oxygen Saturation by Pulse Oximetry ... The study suggests that pulse oximetry is highly accurate for measuring oxygen saturation (SpO2 > 90%) and can replace ABG measurements. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7654494/

Study of Oxygen Saturation by Pulse Oximetry and Arterial ... In the study of Chiappini et al., a significant difference was found between SpO2 and SaO2 values. SpO2 values were lower than SaO2 (90.58±5.45% vs. 92.14±5.79 ...

3. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/pulse-oximetry-report.pdf

Differential Pulse Oximeter Accuracy, Occult Hypoxemia ... VA ESP Project #09-199; 2023. Differential Pulse Oximeter. Accuracy, Occult Hypoxemia. Prevalence, and Clinical Outcomes by Patient Race/Ethnicity.

4. researchgate.net researchgate.net/publication/372641495_Comparative_Analysis_of_Oxygen_Saturation_by_Pulse_Oximetry_and_Arterial_Blood_Gas_in_Hypoxemic_Patients_in_a_Tertiary_Care_Hospital

(PDF) Comparative Analysis of Oxygen Saturation by Pulse ... The study aimed to compare the oxygen saturation levels measured by pulse oximetry and ABG analysis in hypoxemic patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7366881/

Facing SpO2 and SaO2 discrepancies in ICU patients - PMC In a study by van de Louw et al., large differences between SpO2 and SaO2 were found with poor SpO2 reproducibly. Both studies suggested an SpO2 ...

6. fda.gov fda.gov/media/162709/download

FDA Executive Summary Review of Pulse Oximeters and ... measurement of SaO2 and SpO2 paired data and systematically collect data on important confounders, to have more robust evidence about the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03630016

SpO2 Accuracy Comparison of Smart Sock V. 2 ... The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589537022001584

Impact of ethnicity on the accuracy of measurements ... Across the cohort, SpO2 was statistically significantly higher than SaO2 (p < 0.0001), with medians of 98% (interquartile range [IQR]: 95–100%) vs. 97% (IQR: 96 ...

9. cell.com cell.com/iscience/pdf/S2589-0042(23)02232-0.pdf

Evaluating blood oxygen saturation measurements by ... Pearson coefficients suggest a high (r = 0.78, p < 0.001) correlation between the SpO2 values by TPO and the SaO2 references, but rather fair (r ...