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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date June 2024
Source Laval University
Contact n/a
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 (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


Recruitment information / eligibility

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

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 CHU Ste-Justine Montréal Quebec
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
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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