Detection of Propofol in Exhaled Breath

Not Applicable

• Conditions: Healthy
• Interventions: Other: High-performance liquid chromatography Analysis; Device: SMART Device

• Registration Number: NCT02214394
• Lead Sponsor: Xhale Assurance

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-31
• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-07
• Last Update Submitted: 2014-08-07
• Study First Posted: 2014-08-12
• Last Update Posted: 2014-08-12
• Primary Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	High-performance liquid chromatography Analysis	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.
Propofol	SMART Device	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.

Primary Outcome Measures

Name	Time	Method
Comparison of propofol concentrations in exhaled breath to those in plasma	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.)

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States