Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About this trial
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Patients admitted to postoperative cardiac surgery intensive care unit
Presence of an arterial catheter Specific for the extubate patient
Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
Disqualifiers
No SpO2 signal with oximeter in use
False nails or nail polish
Methemoglobinemia >0.015 on last available arterial gas
Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
Trial design
Design model
Crossover
Treatments tested in this trial
Manual Oxygen titration with Philips oximeter (SpO2 target 90%)
DeviceOxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
Manual oxygen titration with Nonin oximeter (SpO2 target 90%)
DeviceOxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
DeviceOxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Manual oxygen titration with Nonin oximeter (SpO2 target 94%)
DeviceOxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Nonin oximeter with a 90% SpO2 targetExperimental treatment 1 intervention
Group B: Philips oximeter with a 90% SpO2 targetExperimental treatment 1 intervention
Group C: Nonin oximeter with a 94% SpO2 targetExperimental treatment 1 intervention
Group D: Philips oximeter with a 94% SpO2 targetExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oxygen flow (or FiO2)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
Time frame
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)Secondary outcomes
1
Difference between SpO2 and SaO2
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)
Time frame
assessed up to 10 minutes - at the same of the arterial blood gases punctionOther outcomes
1
Mean difference on oxymeter
Mean (±SD) of the gaps between the different oximeters tested
Time frame
assessed up to 10 minutes - at the same of the arterial blood gases punction2
Occult hypoxemia
Percentage of occult hypoxemia (SaO2\<90% and SpO2\>=90%)
Time frame
assessed up to 10 minutes - at the same of the arterial blood gases punction3
Occult hyperoxemia
Perrcentage of occult hyperoxemia (SaO2\>96% and SpO2\<=96%)
Time frame
assessed up to 10 minutes - at the same of the arterial blood gases punction4
Partial oxygen weaning
Rate of partial oxygen weaning (Oxygen flow \<=0.5 L/min)
Time frame
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)Sponsors and contacts
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Source ClinicalTrials.gov