Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT05332392
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Masimo INVSENSOR00040
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Clinical Performance of Masimo INVSENSOR00040
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor.
Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: