Respiratory Failure Clinical Trial
— Oxygap 2Official title:
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
NCT number | NCT06102499 |
Other study ID # | 22373 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 30, 2025 |
Verified date | June 2024 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Ste-Justine | Montréal | Quebec |
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 |
---|---|---|---|---|
Other | Hyperoxemia detection | Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg) | During procedure (arterial blood gas sample collection) | |
Other | Gaps between the different oximeters | Average of the SpO2 value gaps between the different oximeters tested | During procedure (arterial blood gas sample collection) | |
Primary | Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between GE oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | |
Primary | Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Nellcor oximeter SpO2 and the SaO2 value | During procedure (arterial blood gassample collection) | |
Primary | Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Masimo oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | |
Primary | Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases | Difference between Nonin oximeter SpO2 and the SaO2 value | During procedure (arterial blood gas sample collection) | |
Secondary | Overestimation and underestimation of SaO2 | Percent of pairs with overestimation and underestimation of SaO2 for each oximeter. | During procedure (arterial blood gas sample collection) | |
Secondary | Hypoxemia detection | Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg) | During procedure (arterial blood gas sample collection) |
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