Detection of Propofol in Exhaled Breath

Xhale

Status: Unknown

Conditions: Healthy

Treatments: Other: High-performance liquid chromatography Analysis; Device: SMART Device

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02214394

20121475-00087006

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

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Propofol

Experimental group

Description:

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.

Treatment:

Device: SMART Device

Other: High-performance liquid chromatography Analysis