Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 4:07 PM
Study NCT ID:
NCT05693961
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2023-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter
Sponsor:
Sky Labs
Organization:
Study Overview
Official Title:
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2023-01
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:
A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.
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?: