Detection of Propofol in Exhaled Breath
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02214394|
Recruitment Status : Unknown
Verified August 2014 by Xhale Assurance.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: High-performance liquid chromatography Analysis Device: SMART Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||October 2014|
Subjects will be given Propofol during routine surgery and then using the SMART Device the breath will be captured and compared to blood plasma using High-performance liquid chromatography Analysis.
Other: High-performance liquid chromatography Analysis
Blood samples will be collected for HPLC analysis to compare with the breath samples.
Device: SMART Device
Breath collection for GC-MS analysis to compare with Blood collection.
Other Name: SMART Breath Based Monitor
- Comparison of propofol concentrations in exhaled breath to those in plasma [ Time Frame: Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour. ]Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214394
|Contact: Donn Dennis, MD||352-371-8488|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Judith Wishin, RN, BSN, CCRC email@example.com|
|Principal Investigator: Timothy E Morey, MD|
|Study Director:||Donn M Dennis, M.D., F.A.H.A.||Xhale, Inc.|