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Propofol Breath Detection for Healthy Subjects

N/A
Waitlist Available
Research Sponsored by Xhale Assurance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a planned surgery or other medical procedure requiring anesthesia
Physical status ASA I, II, or III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
Awards & highlights

Study Summary

This trial will test a new machine that measures how much of the drug propofol is in a person's breath during surgery. The study will see if the machine is as accurate as other ways of measuring propofol levels.

Who is the study for?
This trial is for healthy adults aged 18-65 with a BMI of 18.5 to 30, who are undergoing surgery requiring anesthesia and have an ASA physical status of I, II, or III. It's not for those allergic to propofol components, with lung disease history or tobacco use in the last five years.Check my eligibility
What is being tested?
The study tests an experimental device that measures propofol levels in exhaled breath during surgery and compares its accuracy to traditional blood measurement methods.See study design
What are the potential side effects?
Since this trial involves monitoring rather than administering drugs, there are no direct side effects from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a surgery or procedure that needs anesthesia.
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My health is good to moderately impaired.
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I am between 18 and 65 years old.
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I am a healthy individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
This trial's timeline: 3 weeks for screening, Varies for treatment, and sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of propofol concentrations in exhaled breath to those in plasma

Trial Design

1Treatment groups
Experimental Treatment
Group I: PropofolExperimental Treatment2 Interventions
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.

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Who is running the clinical trial?

Xhale AssuranceLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
271 Previous Clinical Trials
247,005 Total Patients Enrolled
Donn M Dennis, M.D., F.A.H.A.Study DirectorXhale, Inc.

Media Library

SMART Device Clinical Trial Eligibility Overview. Trial Name: NCT02214394 — N/A
SMART Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT02214394 — N/A
Healthy Subjects Research Study Groups: Propofol
Healthy Subjects Clinical Trial 2023: SMART Device Highlights & Side Effects. Trial Name: NCT02214394 — N/A
~1 spots leftby May 2025
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