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OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase

OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04772183
Acronym
OxyGap
Enrollment
300
Registered
2021-02-26
Start date
2021-03-24
Completion date
2025-06-30
Last updated
2024-06-18

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 (Nonin, Masimo, Philips, Nellcor) 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
18 Years to No maximum

Inclusion criteria

* ≥ 18 years old * Patients admitted to the Intensive Care Unit * Artery catheter already installed

Exclusion criteria

* No signal with the oximeter * Pigmented nails or nail polish * Methemoglobinemia * Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19…) * Prone position

Design outcomes

Primary

MeasureTime frameDescription
Diffence between Bejing choice SpO2 and the SaO2 valueDuring arterial blood gase sampleDiffence between Bejing choice oximeter SpO2 and the SaO2 value
Diffence between Nonin ear clip and the SaO2 valueDuring arterial blood gase sampleDiffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value
Diffence between Nellcor SpO2 and the SaO2 valueDuring arterial blood gase sampleDiffence between Nellcor oximeter SpO2 and the SaO2 value
Diffence between Masimo SpO2 and the SaO2 valueDuring arterial blood gase sampleDiffence between Masimo oximeter SpO2 and the SaO2 value
Diffence between Philips SpO2 and the SaO2 valueDuring arterial blood gase sampleDiffence between Philips oximeter SpO2 and the SaO2 value
Diffence between Contec SpO2 and the SaO2 valueDuring arterial blood gase sampleDifffence between Contec oximeter SpO2 and the SaO2 value
Diffence between FreeO2 SpO2 and the SaO2 valueDuring arterial blood gase sampleDiffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value

Secondary

MeasureTime frameDescription
Hypoxemia detectionDuring arterial blood gase sampleAbility to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)
Hyperoxemia detectionDuring arterial blood gase sampleAbility to detect hyperoxemia (SpO2 above 95% and PaO2 \> 100 mmHg)
Gaps between the different oximetersDuring arterial blood gase sampleAverage of the SpO2 value gaps between the different oximeters tested
Finger and ear sensor comparisonDuring arterial blood gase sampleComparison of the finger sensor and ear clip sensor for Nonin oximeter
Overestimation and underestimation of SaO2During arterial blood gase sample% of pairs with overestimation and underestimation of SaO2 for each oximeter.

Countries

Canada

Contacts

Primary ContactFrançois Lellouche
francois.lellouche@criucpq.ulaval.ca418-656-8711
Backup ContactPierre-alexandre Bouchard
pierre-alexandre.bouchard@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

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