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

NCT07168213 | Recruiting

• 1 other identifier: 2026-4432
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  Mean FiO2 in the two last minute of each study period between minute 8 and 10

Secondary Outcomes (5)

• Difference between SpO2 and SaO2

  assessed up to 10 minutes - at the same of the arterial blood gases punction

• High flow weaning criteria

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

• Intensive care unit transfert criteria

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

• Intubation criteria

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

• Mean difference on oxymeter

  assessed up to 10 minutes - at the same of the arterial blood gases punction

Study Arms (4)

Nonin oximeter with a 90% SpO2 target

EXPERIMENTAL

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

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

Philips oximeter with a 90% SpO2 target

EXPERIMENTAL

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

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

Nonin oximeter with a 94% SpO2 target

EXPERIMENTAL

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

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

Philips oximeter with a 94% SpO2 target

EXPERIMENTAL

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

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

Interventions

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

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

Philips oximeter with a 94% SpO2 target

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

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

Philips oximeter with a 90% SpO2 target

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

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

Nonin oximeter with a 90% SpO2 target

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

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

Nonin oximeter with a 94% SpO2 target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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 .

You may not qualify if:

• 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 ...)

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, Quebec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Francois Lellouche Principal Investigator

CONTACT

418-656-8711; francois.lellouche@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 11, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)