Detection of Propofol in Exhaled Breath

Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02214394

Enrollment

Registered

2014-08-12

Start date

2014-08-31

Completion date

Unknown

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

OTHERHigh-performance liquid chromatography Analysis

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

DEVICESMART Device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.)

Countries

United States

Contacts

Primary ContactDonn Dennis, MD

352-371-8488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026