Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04586998
Status:
WITHDRAWN
Last Update Posted:
2021-06-03
First Post:
2020-09-18
Brief Title:
Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor Edmon
Sponsor:
B Braun Melsungen AG
Organization:
B Braun Melsungen AG
Study Overview
Official Title:
Prospective Multicenter Open-Label Single Group Study on the Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Propofol Monitor Edmon in Patients Undergoing Elective Surgery Under Total Intravenous Anaesthesia
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProDect
Brief Summary:
Edmon is the first Communauté Européenne CE marked medical device able to continuously measure propofol in the exhaled breath of patients under sedation or anaesthesia with propofol Current scientific publications indicate that it makes sense from a pharmacologic point of view to measure propofol in the exhaled air
If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath This might be an opportunity for a significant improvement in patient monitoring
If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath This might be an opportunity for a significant improvement in patient monitoring
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?:
None