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

NCT ID: NCT07168213

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nonin oximeter with a 90% SpO2 target

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Philips oximeter with a 90% SpO2 target

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Nonin oximeter with a 94% SpO2 target

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Philips oximeter with a 94% SpO2 target

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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François Lellouche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Francois Lellouche Principal Investigator

Role: CONTACT

418-656-8711 ext. 3572

Other Identifiers

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2026-4432

Identifier Type: -

Identifier Source: org_study_id

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