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Recruiting NCT07168213

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

No phase Interventional Oxygen Delivery Acute Respiratory Failure High Flow Oxygen Therapy Hypoxemic Acute Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual FiO2 titration with Philips oximeter (SpO2 target 90%), Manual FiO2 titration with Nonin oximeter (SpO2 target 90%), Manual FiO2 titration with Philips oximeter (SpO2 target 94%), Manual FiO2 titration with Nonin oximeter (SpO2 target 94%).
Who it may be relevant to
Registry conditions: Oxygen Delivery, Acute Respiratory Failure, High Flow Oxygen Therapy, Hypoxemic Acute Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device Manual FiO2 titration with Philips oximeter (SpO2 target 90%)
    FiO2 titration to reach the SpO2 target (set at 90%) with Philips oximeter
  • Device Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)
    FiO2 titration to reach the SpO2 target (set at 90%) with Nonin oximeter
  • Device Manual FiO2 titration with Philips oximeter (SpO2 target 94%)
    FiO2 titration to reach the SpO2 target (set at 94%) with Philips oximeter
  • Device Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)
    FiO2 titration to reach the SpO2 target (set at 94%) with Nonin oximeter

Primary outcome measures

  • FiO2 [Time frame: Mean FiO2 in the two last minute of each study period between minute 8 and 10]
Secondary outcome measures (5)
  • Difference between SpO2 and SaO2 [Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction]
  • High flow weaning criteria [Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)]
  • Intensive care unit transfert criteria [Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)]
  • Intubation criteria [Time frame: Mean FiO2in the two last minute of each study period (between minute 8 and 10)]
  • Mean difference on oxymeter [Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec

Identifiers

NCT: NCT07168213 · 2026-4432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗