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View on ClinicalTrials.gov

Comparing 4 approaches for oxygen toxicity

Official title: Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation

Condition: Oxygen ToxicitySponsor: Laval UniversityTarget enrollment: 40
  • 4 groups
  • One site, in Québec
  • Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Quebec

Interventions (4)

  • Medical device

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

    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter

  • Medical device

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

    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter

  • Medical device

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

    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

Canadian Sites (1)

1 of 1 recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
  • +SpO2 \< 92% ambient air Specific for the intubate patient FiO2 \<= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 \< 92% with FiO2 0.21
  • +≥ 18 years of age
  • +Presence of an arterial catheter Specific for the extubate patient
  • +Patients admitted to postoperative cardiac surgery intensive care unit

Exclusion

  • 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 ...) Specific for the extubate patient
  • Expected to use another respiratory support within one hour of inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 4 groups in this study.

Group A receives Manual oxygen titration with Nonin oximeter (SpO2 target 90%).

Registry label: A: Nonin oximeter with a 90% SpO2 target

Group B receives Manual Oxygen titration with Philips oximeter (SpO2 target 90%).

Registry label: B: Philips oximeter with a 90% SpO2 target

Group C receives Manual oxygen titration with Nonin oximeter (SpO2 target 94%).

Registry label: C: Nonin oximeter with a 94% SpO2 target

Group D receives Manual Oxygen titration with Philips oximeter (SpO2 target 94%).

Registry label: D: Philips oximeter with a 94% SpO2 target

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 40 people.

The study is currently expected to finish around June 2027.

The main measurement is taken over: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Oxygen flow (or FiO2) — measured over Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05590130 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Manual Oxygen titration with Philips oximeter (SpO2 target 90%)Device

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

About Manual oxygen titration with Nonin oximeter (SpO2 target 90%)Device

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

About Manual Oxygen titration with Philips oximeter (SpO2 target 94%)Device

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

About Manual oxygen titration with Nonin oximeter (SpO2 target 94%)Device

Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10).

The study as a whole is currently expected to finish around 2027-06.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 40 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Québec, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences. The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter. NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.