Respiratory Failure Clinical Trial
— OxyGapOfficial title:
OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHUM | Montréal | Quebec |
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Canada,
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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