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Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy

Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07168213
Enrollment
30
Registered
2025-09-11
Start date
2025-10-21
Completion date
2027-12-01
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, High Flow Oxygen Therapy, Hypoxemic Acute Respiratory Failure, Oxygen Delivery

Brief summary

Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.

Detailed description

The oximeters evaluated will be the Nonin (Plymouth, MN) and the Philips (Eindhoven, Netherlands). Two SpO2 targets will be evaluated: 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.

Interventions

DEVICEManual FiO2 titration with Philips oximeter (SpO2 target 90%)

FiO2 titration to reach the SpO2 target (set at 90%) with Philips oximeter

DEVICEManual FiO2 titration with Nonin oximeter (SpO2 target 90%)

FiO2 titration to reach the SpO2 target (set at 90%) with Nonin oximeter

DEVICEManual FiO2 titration with Philips oximeter (SpO2 target 94%)

FiO2 titration to reach the SpO2 target (set at 94%) with Philips oximeter

DEVICEManual FiO2 titration with Nonin oximeter (SpO2 target 94%)

FiO2 titration to reach the SpO2 target (set at 94%) with Nonin oximeter

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 18 years of age * Admiitted in intensive care unit * Presence of an arterial catheter * Ongoing on high flow nasal oxygen therapy with SpO2 between 88 and 100% with a FiO2 between 40 and 80% with the usual oximeter .

Exclusion criteria

* 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 ...) * Expected to use another respiratory support within two hour of inclusion (NIV or mechanical ventilation)

Design outcomes

Primary

MeasureTime frameDescription
FiO2Mean FiO2 in the two last minute of each study period between minute 8 and 10FiO2 at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter

Secondary

MeasureTime frameDescription
Difference between SpO2 and SaO2assessed up to 10 minutes - at the same of the arterial blood gases punctionDifference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)
High flow weaning criteriaMean FiO2in the two last minute of each study period (between minute 8 and 10)Percentage of patient whose average FiO2 level below 40%
Intensive care unit transfert criteriaMean FiO2in the two last minute of each study period (between minute 8 and 10)Percentage of patients whose average FiO2 level over 60%
Intubation criteriaMean FiO2in the two last minute of each study period (between minute 8 and 10)Percentage of patients whose average FiO2 level over 80%
Mean difference on oxymeterassessed up to 10 minutes - at the same of the arterial blood gases punctionMean (±SD) of the gaps between the different oximeters tested

Countries

Canada

Contacts

CONTACTFrancois Lellouche Principal Investigator
francois.lellouche@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026