SpO2 Target Comparison for High Flow Oxygen Therapy

Overseen By Francois Lellouche Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: No SpO2 signal, Methemoglobinemia, Isolation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 40 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different factors affect oxygen therapy in intensive care patients using high-flow nasal oxygen. The study focuses on two main aspects: the type of device used to measure blood oxygen levels (oximeter) and the specific oxygenation targets set for patients (either 90% or 94%). The goal is to determine how these factors impact the amount of oxygen administered. Patients in intensive care with an arterial catheter and currently using high-flow nasal oxygen therapy may be suitable candidates. The trial aims to improve oxygen delivery by refining monitoring and adjustment methods. As an unphased trial, it offers a unique opportunity to contribute to advancements in oxygen therapy for intensive care patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this oxygen therapy protocol is safe?

Research has shown that high-flow nasal oxygen therapy is generally well-tolerated by patients. Studies have not reported serious side effects directly linked to the targeted oxygen levels or the devices used to measure them.

Nonin and Philips devices are commonly used to monitor oxygen levels, providing accurate readings that help safely adjust the oxygen flow. The standard oxygen level targets of 90% and 94% suggest that the treatment is unlikely to pose significant risks.

Although previous studies did not provide specific data on side effects, such treatments are generally considered safe in clinical settings. Participants should discuss any concerns with their healthcare provider to better understand personal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different oxygen saturation targets and devices might improve high flow oxygen therapy. Unlike standard treatments, which often use fixed oxygen levels, this study investigates personalized oxygen titration using Nonin and Philips oximeters to hit specific SpO2 targets of 90% and 94%. The goal is to understand which combination of device and target provides the best balance of oxygen delivery and patient safety. This could lead to more tailored and effective oxygen therapy protocols, potentially enhancing outcomes for patients requiring respiratory support.

What evidence suggests that this trial's methods for SpO2 target comparison in high-flow oxygen therapy could be effective?

This trial will compare different SpO2 targets and oximeter devices for high-flow oxygen therapy. Studies have shown that the target oxygen level and the type of device used to measure it can affect the amount of oxygen given to patients. For instance, aiming for an oxygen level of 94% with a Nonin oximeter, one of the devices used in this trial, can significantly reduce the oxygen needed compared to aiming for a lower level. Research also shows that a small change, like a 4% difference in target oxygen levels, can more than triple the oxygen required. Finding the right balance is crucial because aiming for levels above 94% can lead to negative effects. These findings highlight the importance of selecting the appropriate oxygen level target and measurement device for effective oxygen therapy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with respiratory issues needing high-flow nasal oxygen therapy. It's not specified who can't join, but typically those with conditions affecting oximeter readings or at risk from varying oxygen levels might be excluded.

Inclusion Criteria

I am on high flow nasal oxygen with specific oxygen levels.

I am 18 years old or older.

I am currently in the intensive care unit.

Exclusion Criteria

Methemoglobinemia >0.015 on last available arterial gas

No SpO2 signal with oximeter in use

Presence of false nails or nail polish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo four 10-minute periods of high-flow nasal oxygen therapy with different oximeters and SpO2 targets

40 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Manual FiO2 titration with Nonin oximeter (SpO2 target 90%)
• Manual FiO2 titration with Nonin oximeter (SpO2 target 94%)
• Manual FiO2 titration with Philips oximeter (SpO2 target 90%)
• Manual FiO2 titration with Philips oximeter (SpO2 target 94%)

Trial Overview The study tests how different SpO2 targets (90% vs. 94%) and types of oximeters (Philips vs. Nonin) affect the amount of oxygen given to patients during therapy.

How Is the Trial Designed?

Group I: Philips oximeter with a 94% SpO2 target Experimental Treatment 1 Intervention

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

Group II: Philips oximeter with a 90% SpO2 target Experimental Treatment 1 Intervention

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

Group III: Nonin oximeter with a 94% SpO2 target Experimental Treatment 1 Intervention

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

Group IV: Nonin oximeter with a 90% SpO2 target Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07168213

Study Details | NCT07168213 | Comparison of Two SpO2 ... During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2. Intervention/ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05590130

NCT05590130 | Comparison of Two Oxygenation Targets ... During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2. Intervention/Treatment ...

3. withpower.com withpower.com/trial/phase-respiratory-insufficiency-9-2025-ed35b

SpO2 Target Comparison for High Flow Oxygen Therapy Trial Overview The study tests how different SpO2 targets (90% vs. 94%) and types of oximeters (Philips vs. Nonin) affect the amount of oxygen given to patients ...

4. clinicaltrial.be clinicaltrial.be/en/details/13882?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Comparison of Two Oxygenation Targets With Two Different... Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753597/

Impact of SpO2 Targets and Pulse Oximeter Brand on ... The choice of the S pO 2 target has been shown to modulate oxygen flow, with an increase by >3-fold for 4% differences in S pO 2 targets.

6. ctv.veeva.com ctv.veeva.com/study/comparison-of-two-oxygenation-targets-with-two-different-oximeters-impact-on-oxygen-flow-rates-and

Impact on Oxygen Flow Rates and Oxygenation During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.