Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5, Canada
Location status: Recruiting
NCT Number: NCT05590130
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Québec, Quebec, G1V4G5, Canada
Location status: Recruiting
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Time frame: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
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: assessed up to 10 minutes - at the same of the arterial blood gases punction
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 punction
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 punction
Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%)
Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction
Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%)
Time frame: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
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)
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)
Time frame: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60)
Contact information is provided by the study sponsor or research team.
Francois Lellouche
CONTACT
418656-8711 ext. 3572
Pierre Alexandre Bouchard
CONTACT
418656-8711 ext. 2712
Laval University
Other
Acronym: Oxygap pong
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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