Detection of Propofol in Exhaled Breath

August 7, 2014 updated by: Xhale Assurance

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
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.
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.
Other Names:
  • SMART Breath Based Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of propofol concentrations in exhaled breath to those in plasma
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xhale Assurance

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Study Director: Donn M Dennis, M.D., F.A.H.A., Xhale, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 20121475-00087006
  • 1R43GM090469-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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