Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102499
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-10-06
Brief Title:
Comparison of Pulse Oximetry SpO2 With Different Oximeters and Arterial Saturation SaO2 Oxygap2 Study
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Comparison of Pulse Oximetry SpO2 With Different Oximeters and Arterial Saturation SaO2 Oxygap2 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oxygap 2
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None