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Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06102499
Acronym
Oxygap 2
Enrollment
200
Registered
2023-10-26
Start date
2024-06-20
Completion date
2026-12-30
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxemia, Hypoxemia, Respiratory Failure

Brief summary

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign. Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy. Thus, this study aims to compare the SpO2 values of different oximeters (General Electric-GE, Medtronic, Masimo and Nonin) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation

Interventions

Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

Sponsors

Laval University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Adult population Inclusion Criteria: * ≥ 18 years old (adult population) - * Patients admitted to the Intensive Care Unit * Artery catheter already installed Pediatric population * Below 18 years old * Patients admitted to the Intensive Care Unit * Artery catheter already installed

Exclusion criteria

* No or poor signal with the usual pulse oximeter/based on clinician judgment * High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L) * Pigmented nails or nail polish * Methemoglobinemia history * Hemoglobin below 80 g/L * Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…) * Prone position, Extra Corporel Membrane Oxygenator

Design outcomes

Primary

MeasureTime frameDescription
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gasesDuring procedure (arterial blood gas sample collection)Difference between Nonin oximeter SpO2 and the SaO2 value
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gasesDuring procedure (arterial blood gas sample collection)Difference between GE oximeter SpO2 and the SaO2 value
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gasesDuring procedure (arterial blood gassample collection)Difference between Nellcor oximeter SpO2 and the SaO2 value
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gasesDuring procedure (arterial blood gas sample collection)Difference between Masimo oximeter SpO2 and the SaO2 value

Secondary

MeasureTime frameDescription
Overestimation and underestimation of SaO2During procedure (arterial blood gas sample collection)Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.
Hypoxemia detectionDuring procedure (arterial blood gas sample collection)Ability to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)

Other

MeasureTime frameDescription
Hyperoxemia detectionDuring procedure (arterial blood gas sample collection)Ability to detect hyperoxemia (SpO2 above 95% and PaO2 \> 100 mmHg)
Gaps between the different oximetersDuring procedure (arterial blood gas sample collection)Average of the SpO2 value gaps between the different oximeters tested

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026