Puerperal: [Major Infection] or [Sepsis]NCT02532959
Diagnostic Breath Analysis Study to Detect Sepsis
An observational study of Puerperal: [Major Infection] or [Sepsis], run by Landon Pediatric Foundation at 1 site in United States.
Trial summary
Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Puerperal: [Major Infection] or [Sepsis]
- What is being tested?
- Diagnostic Breath Analysis
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2015
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients enter through Emergency Room, are identified at risk for SIRS
Who may be able to join
- Age 18 years of age or older
- Able to give written and dated informed consent prior to any study specific procedures.
- Able to follow instructions for specific breathing maneuvers.
- Able to breath into a medical grade tube, vial or bag.
- Initial assessment and screening indicates SIRS or Sepsis.
Who cannot join
- Cognitively impaired and unable to complete informed consent documents.
- Unable to follow instructions during testing.
- Severe dyspnea.
- Use of supplement oxygen which cannot be discontinued during testing.
- Unable to perform breathing maneuvers required to provide multiple breath samples.
- Swallowing disorders or chronic aspiration.
Show all 10Show fewer
- History of pneumothorax.
- Patients requiring mechanical ventilation
- Patients who are pregnant.
- Patients who have smoked cigarettes or cigars within 30 days prior to trial admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ventura County Medical Center
Ventura, California, 93003
About this study
Official title: Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis.
Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.
Read the detailed description
Exhaled breath samples were collected in a Tedlar bag or with a proprietary collection tube. The collection devices are clean and intended for single-use. They are manufactured with approved medical grade materials. Patients were asked to breath into a single-use, medical grade mouthpiece which is connected to the collection bag or tube. The design of the collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients enrolled in the clinical study were asked to breathe into the breath collection device for 2 to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30 days and retested at the end of the 30 day period to determine if the VOC profile has changed over time.
- Conditions
- Puerperal: [Major Infection] or [Sepsis]
- Being tested
- Diagnostic Breath Analysis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Breath AnalysisDevice
Conduct exhaled breath samples
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Breath Analysis | Patients at risk of SIRS Receives: Device: Diagnostic Breath Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Breath Analysis
Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puerperal: [Major Infection] or [Sepsis]Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crhis Landon, MD, Principal investigator, Ventura County Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532959
- Sponsor's protocol ID
- Study:177
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
- ClinicalTrials.gov ID
- NCT02532959
- Acronym / sponsor ID
- Study:177
- Conditions
- Puerperal: [Major Infection] or [Sepsis]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Aug 2015 (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.
Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis.
Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.
Detailed description
Exhaled breath samples were collected in a Tedlar bag or with a proprietary collection tube. The collection devices are clean and intended for single-use. They are manufactured with approved medical grade materials. Patients were asked to breath into a single-use, medical grade mouthpiece which is connected to the collection bag or tube. The design of the collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients enrolled in the clinical study were asked to breathe into the breath collection device for 2 to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30 days and retested at the end of the 30 day period to determine if the VOC profile has changed over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Breath Analysis | – | Device: Diagnostic Breath AnalysisPatients at risk of SIRS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enter through Emergency Room, are identified at risk for SIRS
Key inclusion criteria (5 listed)
- Age 18 years of age or older
- Able to give written and dated informed consent prior to any study specific procedures.
- Able to follow instructions for specific breathing maneuvers.
- Able to breath into a medical grade tube, vial or bag.
- Initial assessment and screening indicates SIRS or Sepsis.
Key exclusion criteria (10 listed)
- Cognitively impaired and unable to complete informed consent documents.
- Unable to follow instructions during testing.
- Severe dyspnea.
- Use of supplement oxygen which cannot be discontinued during testing.
- Unable to perform breathing maneuvers required to provide multiple breath samples.
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 |
|---|---|---|
| Diagnostic Breath AnalysisConduct exhaled breath samples | Device | Diagnostic Breath Analysis |
Primary outcome
Diagnostic Breath Analysis
Time frame: 6 months
Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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.
Crhis Landon, MD principal investigator
Ventura County Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Puerperal: [Major Infection] or [Sepsis], run by Landon Pediatric Foundation 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 10 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: finished, as of the sponsor's last update on 8 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Breath Analysis (time frame: 6 months). 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 8 Sep 2016.