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Recruiting NCT06102499

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

— Observational Respiratory Failure Hypoxemia Hyperoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SpO2 and SaO2 comparison.
Who it may be relevant to
Registry conditions: Respiratory Failure, Hypoxemia, Hyperoxemia. Basic parameters: 0 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • Device SpO2 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

Primary outcome measures

  • Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases [Time frame: During procedure (arterial blood gas sample collection)]
  • Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases [Time frame: During procedure (arterial blood gassample collection)]
  • Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases [Time frame: During procedure (arterial blood gas sample collection)]
  • Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases [Time frame: During procedure (arterial blood gas sample collection)]
Secondary outcome measures (2)
  • Overestimation and underestimation of SaO2 [Time frame: During procedure (arterial blood gas sample collection)]
  • Hypoxemia detection [Time frame: During procedure (arterial blood gas sample collection)]

Eligibility criteria

Adult population

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 3 centers
  • CHUM — Montreal
  • CHU Ste-Justine — Montreal
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec

Identifiers

NCT: NCT06102499 · 22373

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗