Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516809
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
Status:
COMPLETED
Status Verified Date:
2024-07
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 purpose of the study is to determine the accuracy of the Dormotech VLAB SpO2 Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions 510ks in range of arterial HbO2 saturations from 100 down to 70
This was a prospective study with healthy volunteers
The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70 As the primary endpoint the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation arterial blood sample processed in a multi-wavelength hemoximeter
This was a prospective study with healthy volunteers
The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70 As the primary endpoint the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation arterial blood sample processed in a multi-wavelength hemoximeter
Detailed Description:
The purpose of the study is to determine the accuracy of the Dormotech VLAB SpO2 Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions 510ks in the range of arterial HbO2 saturations from 100 down to 70
The subjects represent a diverse group in terms of age height weight ethnicity and skin types which is beneficial for generalizing findings across different demographics Subjects span all six types indicating a wide range of skin types from very fair Type I to deeply pigmented dark Type VI
This was a prospective study with healthy volunteers
The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70 As the primary endpoint the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation arterial blood sample processed in a multi-wavelength hemoximeter
The subjects represent a diverse group in terms of age height weight ethnicity and skin types which is beneficial for generalizing findings across different demographics Subjects span all six types indicating a wide range of skin types from very fair Type I to deeply pigmented dark Type VI
This was a prospective study with healthy volunteers
The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70 As the primary endpoint the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation arterial blood sample processed in a multi-wavelength hemoximeter
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