Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634693
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy of Pulse Oximeters with Profound Hypoxia
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study The overall framework of the validation process followed Annex EE2 of ISO 80601-2-612019
Detailed Description:
The TipTraQ is a finger-based wearable for aiding OSA diagnosis at home that consists of a sensor placed on a fingertip PPG data are produced by a reflective emitter and photodetector elements from one of the fingertips TipTraQ Companion app can read and record the PPG signals from the TipTraQ Sensor and further transmit the data to TipTraQ Cloud
The overall framework is a controlled desaturation study follows the Annex EE2 of ISO 80601-2-612019 A radial arterial cannula was placed in each subjects left or right wrist for blood sampling and monitoring blood pressure Each subject had two control blood samples taken at the beginning of each experiment while breathing room air Hands with pulse oximeters were maintained motionless on arm boards Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation between 70-100 by having subjects breathe mixtures of nitrogen air and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeter readings were stable During the procedure the subject is under stationary status Two arterial blood samples were then obtained approximately 30 seconds apart Each stable plateau therefore was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3 The plateaus were nominally at 100 room air saturation 93 90 87 85 82 80 77 75 and 70 At least 200 data points were collected for each type of oximeter and probe combination studied
The overall framework is a controlled desaturation study follows the Annex EE2 of ISO 80601-2-612019 A radial arterial cannula was placed in each subjects left or right wrist for blood sampling and monitoring blood pressure Each subject had two control blood samples taken at the beginning of each experiment while breathing room air Hands with pulse oximeters were maintained motionless on arm boards Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation between 70-100 by having subjects breathe mixtures of nitrogen air and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeter readings were stable During the procedure the subject is under stationary status Two arterial blood samples were then obtained approximately 30 seconds apart Each stable plateau therefore was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3 The plateaus were nominally at 100 room air saturation 93 90 87 85 82 80 77 75 and 70 At least 200 data points were collected for each type of oximeter and probe combination studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None