Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06634693
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2024-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
Sponsor:
PranaQ Pte. Ltd.
Organization:
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:
False
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 EE.2 of ISO 80601-2-61:2019.
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 EE.2 of ISO 80601-2-61:2019. A radial arterial cannula was placed in each subject's 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 EE.2 of ISO 80601-2-61:2019. A radial arterial cannula was placed in each subject's 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 21-35637 | REGISTRY | Accuracy of pulse oximeters with profound hypoxia | View |