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Clinical Trials/NCT04772183
NCT04772183
Recruiting
Not Applicable

OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood

Laval University2 sites in 1 country300 target enrollmentMarch 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Laval University
Enrollment
300
Locations
2
Primary Endpoint
Diffence between Masimo SpO2 and the SaO2 value
Status
Recruiting
Last Updated
last year

Overview

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 (Nonin, Masimo, Philips, Nellcor) 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

Registry
clinicaltrials.gov
Start Date
March 24, 2021
End Date
June 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

François Lellouche

Principal investigator

Laval University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • No signal with the oximeter
  • Pigmented nails or nail polish
  • Methemoglobinemia
  • Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19...)
  • Prone position

Outcomes

Primary Outcomes

Diffence between Masimo SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Masimo oximeter SpO2 and the SaO2 value

Diffence between Nellcor SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Nellcor oximeter SpO2 and the SaO2 value

Diffence between Nonin ear clip and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value

Diffence between Philips SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Philips oximeter SpO2 and the SaO2 value

Diffence between FreeO2 SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value

Diffence between Contec SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Difffence between Contec oximeter SpO2 and the SaO2 value

Diffence between Bejing choice SpO2 and the SaO2 value

Time Frame: During arterial blood gase sample

Diffence between Bejing choice oximeter SpO2 and the SaO2 value

Secondary Outcomes

  • Hyperoxemia detection(During arterial blood gase sample)
  • Gaps between the different oximeters(During arterial blood gase sample)
  • Overestimation and underestimation of SaO2(During arterial blood gase sample)
  • Hypoxemia detection(During arterial blood gase sample)
  • Finger and ear sensor comparison(During arterial blood gase sample)

Study Sites (2)

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