Detection of Propofol in Exhaled Breath

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02214394
• Other study ID #: 20121475-00087006
• Secondary ID: 1R43GM090469-01A
• Status: Not yet recruiting
• Phase: N/A
• First received: July 31, 2014
• Last updated: August 7, 2014
• Start date: August 2014

Study information

• Verified date: August 2014
• Source: Xhale Assurance
• Contact: Donn Dennis, MD
• Phone: 352-371-8488
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Xhale Assurance	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No