Detection of Propofol in Exhaled Breath

Xhale Assurance15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

High-performance liquid chromatography AnalysisOTHER

Blood samples will be collected for HPLC analysis to compare with the breath samples.

SMART DeviceDEVICE

Breath collection for GC-MS analysis to compare with Blood collection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.)

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.

Central Contacts

Donn Dennis, MD

CONTACT

352-371-8488

Data from ClinicalTrials.gov

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