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

ConditionsOxygen DeliveryAcute Respiratory FailureHigh Flow Oxygen TherapyHypoxemic Acute Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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 .

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 ...)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Manual FiO2 titration with Philips oximeter (SpO2 target 90%)

    Device

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

  • Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)

    Device

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

  • Manual FiO2 titration with Philips oximeter (SpO2 target 94%)

    Device

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

  • Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)

    Device

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

Treatment groups

30 Participants
are divided into 4 treatment groups
Group 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

FiO2

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 FiO2 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 punction
2

High flow weaning criteria

Percentage of patient whose average FiO2 level below 40%

Time frame
Mean FiO2in the two last minute of each study period (between minute 8 and 10)
3

Intensive care unit transfert criteria

Percentage of patients whose average FiO2 level over 60%

Time frame
Mean FiO2in the two last minute of each study period (between minute 8 and 10)
4

Intubation criteria

Percentage of patients whose average FiO2 level over 80%

Time frame
Mean FiO2in the two last minute of each study period (between minute 8 and 10)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Source ClinicalTrials.gov
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