Detection of Propofol in Exhaled Breath

NCT ID: NCT02214394

Last Updated: 2014-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High-performance liquid chromatography Analysis

Intervention Type OTHER

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

SMART Device

Intervention Type DEVICE

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

Interventions

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High-performance liquid chromatography Analysis

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

Intervention Type OTHER

SMART Device

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

Intervention Type DEVICE

Other Intervention Names

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SMART Breath Based Monitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Xhale Assurance

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donn M Dennis, M.D., F.A.H.A.

Role: STUDY_DIRECTOR

Xhale, Inc.

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Donn Dennis, MD

Role: CONTACT

352-371-8488

Facility Contacts

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Judith Wishin, RN, BSN, CCRC

Role: primary

Other Identifiers

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1R43GM090469-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20121475-00087006

Identifier Type: -

Identifier Source: org_study_id

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