Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267976
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-02-12
Brief Title:
Validation of the ProSomnus RPMO2 Device
Sponsor:
ProSomnus Sleep Technologies
Organization:
ProSomnus Sleep Technologies
Study Overview
Official Title:
Validation of the ProSomnus RPMO2 Pulse Oximeter Device
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 purpose of the study is to
1 Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100 SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter
2 Evaluate the pulse rate performance simultaneously collected over the SpO2 range
1 Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100 SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter
2 Evaluate the pulse rate performance simultaneously collected over the SpO2 range
Detailed Description:
Testing will be performed with participants semi-recumbent under non-motion conditions SpO2 accuracy of the test device will be determined by a controlled desaturation study with measurements taken over the full range of SaO2 values for which accuracy is to be claimed 3 of the lower value and -3 of the upper value Participants will be desaturated to achieve six plateaus between 100-70 SaO2
Arterial blood draws within the hypoxic plateaus will be performed with draws occurring no less than 30 seconds after reaching a plateau and no less than 20 seconds apart Five blood draws will be taken at each plateau Plateaus will be determined using the reference transmittance pulse oximeter and are defined as a change in SpO2 on the reference pulse oximeter of no more than 1 over a duration of 20 seconds Sampling will not continue if the blood oxygen saturation destabilizes between blood draws
Time in low O2 saturation decades ie 70-80 and 80-90 will be limited to the minimum amount of time required to obtain test data and will not exceed 10 minutes The saturation level at each plateau and the number of plateaus may vary among participants Arterial pressure ECG heart rate EtCO2 respiratory rate and FiO2 will be monitored during testing Extra samples may be collected at the discretion of the PI The controlled desaturation protocol is expected to take approximately 30 to 60 minutes
Arterial blood draws within the hypoxic plateaus will be performed with draws occurring no less than 30 seconds after reaching a plateau and no less than 20 seconds apart Five blood draws will be taken at each plateau Plateaus will be determined using the reference transmittance pulse oximeter and are defined as a change in SpO2 on the reference pulse oximeter of no more than 1 over a duration of 20 seconds Sampling will not continue if the blood oxygen saturation destabilizes between blood draws
Time in low O2 saturation decades ie 70-80 and 80-90 will be limited to the minimum amount of time required to obtain test data and will not exceed 10 minutes The saturation level at each plateau and the number of plateaus may vary among participants Arterial pressure ECG heart rate EtCO2 respiratory rate and FiO2 will be monitored during testing Extra samples may be collected at the discretion of the PI The controlled desaturation protocol is expected to take approximately 30 to 60 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None