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RecruitingNCT06102499Oxygap 2Updated Aug 28, 2025

Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

An observational study in Respiratory Failure, Hypoxemia and Hyperoxemia, sponsored by Laval University. Recruiting at 3 sites in Canada. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Laval University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
0 Years to 100 Years
Sex
All
01

Study summary

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (General Electric-GE, Medtronic, Masimo and Nonin) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation

02

Conditions studied

  • Respiratory Failure
  • Hypoxemia
  • Hyperoxemia
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patient in ICU with arterial catheter already installed will be consider

Adult population

Inclusion criteria

Inclusion Criteria:

  • ≥ 18 years old (adult population) -
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed

Pediatric population

  • Below 18 years old
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed

Exclusion criteria

Exclusion Criteria:

  • No or poor signal with the usual pulse oximeter/based on clinician judgment
  • High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
  • Pigmented nails or nail polish
  • Methemoglobinemia history
  • Hemoglobin below 80 g/L
  • Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…)
  • Prone position, Extra Corporel Membrane Oxygenator
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pediatric population

    Pediatric population \< 18 years old (estimated 100 patients)

    Device: SpO2 and SaO2 comparison

  • Adult population

    Adult population \>or= 18 years old (estimated 100 patients)

    Device: SpO2 and SaO2 comparison

Interventions

  • DeviceSpO2 and SaO2 comparison

    Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

06

What researchers measure

Primary outcomes

  1. Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases

    Difference between GE oximeter SpO2 and the SaO2 value

    Time frame: During procedure (arterial blood gas sample collection)

  2. Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases

    Difference between Nellcor oximeter SpO2 and the SaO2 value

    Time frame: During procedure (arterial blood gassample collection)

  3. Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases

    Difference between Masimo oximeter SpO2 and the SaO2 value

    Time frame: During procedure (arterial blood gas sample collection)

  4. Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases

    Difference between Nonin oximeter SpO2 and the SaO2 value

    Time frame: During procedure (arterial blood gas sample collection)

Secondary outcomes

  1. Overestimation and underestimation of SaO2

    Percent of pairs with overestimation and underestimation of SaO2 for each oximeter.

    Time frame: During procedure (arterial blood gas sample collection)

  2. Hypoxemia detection

    Ability to detect hypoxemia (SpO2 below 90% and PaO2 \< 60 mmHg)

    Time frame: During procedure (arterial blood gas sample collection)

Other outcomes

  1. Hyperoxemia detection

    Ability to detect hyperoxemia (SpO2 above 95% and PaO2 \> 100 mmHg)

    Time frame: During procedure (arterial blood gas sample collection)

  2. Gaps between the different oximeters

    Average of the SpO2 value gaps between the different oximeters tested

    Time frame: During procedure (arterial blood gas sample collection)

07

Study locations

1 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06102499
Lead sponsor
Laval University
Responsible party
François Lellouche (Principal Investigator, Laval University) — Principal investigator
First posted
Oct 26, 2023
Start date
Jun 20, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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