Recruiting

Pulse Oximetry

Sponsor:

Laval University

Code:

NCT06102499

Conditions

Respiratory Failure

Hypoxemia

Hyperoxemia

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

SpO2 and SaO2 comparison

Study Details

Brief 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

Conditions

Respiratory Failure

Hypoxemia

Hyperoxemia

Study ID

NCT06102499

Start date

Jun 20, 2024

Status verified date

Aug, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric population

Pediatric population < 18 years old (estimated 100 patients)

Adult population

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

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X0A9

Contacts

Emmanuel Charbonney

514-890-8000emmanuel.charbonney@umontreal.ca

More Information

Sponsor

Laval University

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-08-28.