Detection of Propofol in Exhaled Breath
Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.
2 other identifiers
interventional
15
1 country
1
Brief Summary
This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedAugust 12, 2014
August 1, 2014
2 months
July 31, 2014
August 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of propofol concentrations in exhaled breath to those in plasma
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.)
Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
Study Arms (1)
Propofol
EXPERIMENTALSubjects 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.
Interventions
Blood samples will be collected for HPLC analysis to compare with the breath samples.
Breath collection for GC-MS analysis to compare with Blood collection.
Eligibility Criteria
You may qualify if:
- Be between 18 and 65 years old
- Healthy Male or Female
- BMI between 18.5 and 30.0
- Have a planned surgery or other medical procedure requiring anesthesia
- Physical status ASA I, II, or III
You may not qualify if:
- Known allergy to any component of propofol formulation components
- History of lung disease or tobacco use in the past 5 years
- Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32608, United States
Study Officials
- STUDY DIRECTOR
Donn M Dennis, M.D., F.A.H.A.
Xhale, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 12, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2014
Last Updated
August 12, 2014
Record last verified: 2014-08