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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04772183
Other study ID # 2021-3624
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 24, 2021
Est. completion date June 30, 2025

Study information

Verified date June 2024
Source Laval University
Contact François Lellouche
Phone 418-656-8711
Email francois.lellouche@criucpq.ulaval.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Canada CHUM Montréal Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diffence between Nellcor SpO2 and the SaO2 value Diffence between Nellcor oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between FreeO2 SpO2 and the SaO2 value Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between Nonin ear clip and the SaO2 value Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between Masimo SpO2 and the SaO2 value Diffence between Masimo oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between Philips SpO2 and the SaO2 value Diffence between Philips oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between Contec SpO2 and the SaO2 value Difffence between Contec oximeter SpO2 and the SaO2 value During arterial blood gase sample
Primary Diffence between Bejing choice SpO2 and the SaO2 value Diffence between Bejing choice oximeter SpO2 and the SaO2 value During arterial blood gase sample
Secondary Overestimation and underestimation of SaO2 % of pairs with overestimation and underestimation of SaO2 for each oximeter. During arterial blood gase sample
Secondary Hypoxemia detection Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg) During arterial blood gase sample
Secondary Hyperoxemia detection Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg) During arterial blood gase sample
Secondary Gaps between the different oximeters Average of the SpO2 value gaps between the different oximeters tested During arterial blood gase sample
Secondary Finger and ear sensor comparison Comparison of the finger sensor and ear clip sensor for Nonin oximeter During arterial blood gase sample
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