OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaval University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old
Patients admitted to the Intensive Care Unit
Artery catheter already installed
Disqualifiers
No signal with the oximeter
Pigmented nails or nail polish
Methemoglobinemia
Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19…)
Trial population
All patient in ICU with arterial catheter already installed will be consider.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SpO2 and SaO2 comparison
DeviceSeveral pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diffence between Nellcor SpO2 and the SaO2 value
Diffence between Nellcor oximeter SpO2 and the SaO2 value
Time frame
During arterial blood gase sample2
Diffence between FreeO2 SpO2 and the SaO2 value
Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value
Time frame
During arterial blood gase sample3
Diffence between Nonin ear clip and the SaO2 value
Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value
Time frame
During arterial blood gase sample4
Diffence between Masimo SpO2 and the SaO2 value
Diffence between Masimo oximeter SpO2 and the SaO2 value
Time frame
During arterial blood gase sampleSecondary outcomes
1
Overestimation and underestimation of SaO2
% of pairs with overestimation and underestimation of SaO2 for each oximeter.
Time frame
During arterial blood gase sample2
Hypoxemia detection
Ability to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)
Time frame
During arterial blood gase sample3
Hyperoxemia detection
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 \> 100 mmHg)
Time frame
During arterial blood gase sample4
Gaps between the different oximeters
Average of the SpO2 value gaps between the different oximeters tested
Time frame
During arterial blood gase sampleSponsors and contacts
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Source ClinicalTrials.gov