Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-100
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 (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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old (adult population) -
Patients admitted to the Intensive Care Unit
Artery catheter already installed
Below 18 years old
Disqualifiers
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
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
200 Participants
are divided into 2 treatment groupsGroup A: Pediatric population1 intervention
Group B: Adult population1 intervention
Trial outcomes
Primary outcomes
1
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between GE oximeter SpO2 and the SaO2 value
Time frame
During procedure (arterial blood gas sample collection)2
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Nellcor oximeter SpO2 and the SaO2 value
Time frame
During procedure (arterial blood gassample collection)3
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Masimo oximeter SpO2 and the SaO2 value
Time frame
During procedure (arterial blood gas sample collection)4
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
Difference between Nonin oximeter SpO2 and the SaO2 value
Time frame
During procedure (arterial blood gas sample collection)Secondary outcomes
1
Overestimation and underestimation of SaO2
Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.
Time frame
During procedure (arterial blood gas sample collection)2
Hypoxemia detection
Ability to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)
Time frame
During procedure (arterial blood gas sample collection)Other outcomes
1
Hyperoxemia detection
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 \> 100 mmHg)
Time frame
During procedure (arterial blood gas sample collection)2
Gaps between the different oximeters
Average of the SpO2 value gaps between the different oximeters tested
Time frame
During procedure (arterial blood gas sample collection)Sponsors and contacts
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Source ClinicalTrials.gov