HealthyNCT02214394
Detection of Propofol in Exhaled Breath
A study testing High-performance liquid chromatography Analysis and SMART Device in people with Healthy, run by Xhale Assurance at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-performance liquid chromatography Analysis and SMART Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Donn Dennis, MD contact
United States1 site
University of Florida
Gainesville, Florida, 32608
Judith Wishin, RN, BSN, CCRC, jwishin@anest.ufl.edu
Timothy E Morey, MD
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- High-performance liquid chromatography Analysis, SMART Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-performance liquid chromatography AnalysisOther
Blood samples will be collected for HPLC analysis to compare with the breath samples.
SMART DeviceDevice
Also called SMART Breath Based Monitor
Breath collection for GC-MS analysis to compare with Blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | 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. Receives: Other: High-performance liquid chromatography Analysis; Device: SMART Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xhale Assurance
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Donn M Dennis, M.D., F.A.H.A., Study director, Xhale, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214394
- Sponsor's protocol ID
- 20121475-00087006
- Other IDs
- 1R43GM090469-01A1
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.
- ClinicalTrials.gov ID
- NCT02214394
- Acronym / sponsor ID
- 20121475-00087006
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xhale AssuranceIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Other: High-performance liquid chromatography Analysis, Device: SMART DeviceSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-performance liquid chromatography AnalysisBlood samples will be collected for HPLC analysis to compare with the breath samples. | Other | Propofol |
| SMART DeviceAlso: SMART Breath Based MonitorBreath collection for GC-MS analysis to compare with Blood collection. | Device | Propofol |
Primary outcome
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.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donn Dennis, MD contact
Donn M Dennis, M.D., F.A.H.A. study director
Xhale, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-performance liquid chromatography Analysis and SMART Device in people with Healthy, run by Xhale Assurance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donn Dennis, MD (352-371-8488), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.