RecruitingNCT06102499

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


Sponsor

Laval University

Enrollment

200 participants

Start Date

Jun 20, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 0 YearsMax Age: 100 Years

Inclusion Criteria8

  • Adult population
  • ≥ 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 Criteria7

  • 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

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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


Locations(3)

CHUM

Montreal, Quebec, Canada

CHU Ste-Justine

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

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NCT06102499


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