Air Leak From LungNCT06548386
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
A study testing Pleural gas analysis in people with Air Leak From Lung and Pneumothorax, run by Lung Healing Technologies Inc at 1 site in United States.
Trial summary
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung, Pneumothorax
- What is being tested?
- Pleural gas analysis
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for thoracic surgery and expected to have chest tube placed
- For patients who are unable to sign consent, but meet all of the inclusion criteria and none of the exclusion criteria, a legally appointed representative (LAR) will be allowed to sign consent for that patient
- Patients that provide informed consent for the study
- Patients \>18 years old
Who cannot join
- Patients with hemodynamic instability
- Pregnant patients
- Prisoners
- Individuals who are not yet adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Kanwal Zeeshan
About this study
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks. The investigators have developed prototype gas analyzers that attach to the outlet of any analog chest drain, and can be connected temporarily to the sampling port. They detect breath by measuring CO2, O2, and pressure, in order to supplement the information provided by the bubbles in the water seal.
Read the detailed description
Tests on patients in 2013 at Northwestern demonstrated that gas analysis can help diagnose and heal air leaks by detecting breath in chest drains, as documented in the investigator's patents and peer-reviewed publications. CO2 is 100 times higher in the lung than ambient, and O2 the same amount lower in ppm. The length of time that it takes to detect breath at the outlet is related to the size of the air leak. O2 is available next to every bed, often used in recovery, and when high O2 is quickly detected at the sampling port, the only source can be an active air leak.
The primary aim is to assess whether the device can accurately measure changes in gas flow from an analog pleural drain and whether this accurately detects pleural air leaks.
Specific aim 1: To determine whether the gas analyzer device can measure changes in exhaled gas levels and if this can distinguish true air leaks from false air leaks.
Sub aim 1: Assess how patient characteristics such as extent of resection, pre-existing conditions such as COD, lung function test, etc, affect the efficacy of the device.
Specific aim 2: Compare the accuracy of pleural air leak measured via gas analysis to the accuracy of pleural air leak detection as measured by standard VI.
The hypothesis is that the prototype pleural gas analyzer, through detection of carbon dioxide and oxygen levels, can distinguish true air leaks from false air leaks more accurately than the traditionally practiced method of Visual Inspection of bubbles in the chest drainage unit (VI).
Study Endpoints:
The primary end point of this study is detection of air leak, either by VI or prototype pleural gas analysis.
True Air Leak Definition:
- Both visual inspection and pleural gas analysis demonstrate an air leak
- Development of a pneumothorax at any point up to 4 weeks after chest tube removal
- Pneumothorax develops during a clamp trial to assess for true air leak (failed clamp trial)
- Patient discharged home with chest tube due to clinical concern (even in absence of clamp trial) of ongoing air leak
- Development of clinically significant subcutaneous emphysema either with a chest tube in place or after chest tube removal (defined as an increase beyond initial post op, observable to patient or care team) Secondary endpoint is comparison in accuracy in detection of air leak between VI and gas analysis.
- Conditions
- Air Leak From Lung, Pneumothorax
- Being tested
- Pleural gas analysis
- Keywords
- alveolopleural fistula
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural gas analysisDevice
Patients enrolled in this study will undergo both VI and pleural gas analysis to assess for air leak following surgical chest tube placement.
For pleural gas analysis, an outlet gas analyzer will be kept on the outlet port of the chest drain for the entire duration of time that a chest tube is in place. We plan to collect both continuous data, looking for intermittent spikes and gas changes, along with episodic data collected during specific air leak assessments. The gas analyzer may better be able to measure an air leak during these specific procedures conducted twice per day, but it will also be used at the outlet port of the chest drain the rest of the time to continuously check for an air leak throughout the hospital stay.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy alone
Whether gas analysis can accurately assess for air leak
Measured: One year
Secondary outcomes (1)
Using VI as well
Comparison of accuracy in air leak assessment between gas analysis and visual inspection
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start5 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lung Healing Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548386
- Sponsor's protocol ID
- STUDY00000003
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
- ClinicalTrials.gov ID
- NCT06548386
- Acronym / sponsor ID
- STUDY00000003
- Conditions
- Air Leak From Lung, Pneumothorax
- Keywords
- alveolopleural fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Lung Healing Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Aug 2024 (actual)
- 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.
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks. The investigators have developed prototype gas analyzers that attach to the outlet of any analog chest drain, and can be connected temporarily to the sampling port. They detect breath by measuring CO2, O2, and pressure, in order to supplement the information provided by the bubbles in the water seal.
Detailed description
Tests on patients in 2013 at Northwestern demonstrated that gas analysis can help diagnose and heal air leaks by detecting breath in chest drains, as documented in the investigator's patents and peer-reviewed publications. CO2 is 100 times higher in the lung than ambient, and O2 the same amount lower in ppm. The length of time that it takes to detect breath at the outlet is related to the size of the air leak. O2 is available next to every bed, often used in recovery, and when high O2 is quickly detected at the sampling port, the only source can be an active air leak.
The primary aim is to assess whether the device can accurately measure changes in gas flow from an analog pleural drain and whether this accurately detects pleural air leaks.
Specific aim 1: To determine whether the gas analyzer device can measure changes in exhaled gas levels and if this can distinguish true air leaks from false air leaks.
Sub aim 1: Assess how patient characteristics such as extent of resection, pre-existing conditions such as COD, lung function test, etc, affect the efficacy of the device.
Specific aim 2: Compare the accuracy of pleural air leak measured via gas analysis to the accuracy of pleural air leak detection as measured by standard VI.
The hypothesis is that the prototype pleural gas analyzer, through detection of carbon dioxide and oxygen levels, can distinguish true air leaks from false air leaks more accurately than the traditionally practiced method of Visual Inspection of bubbles in the chest drainage unit (VI).
Study Endpoints:
The primary end point of this study is detection of air leak, either by VI or prototype pleural gas analysis.
True Air Leak Definition:
- Both visual inspection and pleural gas analysis demonstrate an air leak
- Development of a pneumothorax at any point up to 4 weeks after chest tube removal
- Pneumothorax develops during a clamp trial to assess for true air leak (failed clamp trial)
- Patient discharged home with chest tube due to clinical concern (even in absence of clamp trial) of ongoing air leak
- Development of clinically significant subcutaneous emphysema either with a chest tube in place or after chest tube removal (defined as an increase beyond initial post op, observable to patient or care team) Secondary endpoint is comparison in accuracy in detection of air leak between VI and gas analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are scheduled for thoracic surgery and expected to have chest tube placed
- For patients who are unable to sign consent, but meet all of the inclusion criteria and none of the exclusion criteria, a legally appointed representative (LAR) will be allowed to sign consent for that patient
- Patients that provide informed consent for the study
- Patients \>18 years old
Key exclusion criteria (4 listed)
- Patients with hemodynamic instability
- Pregnant patients
- Prisoners
- Individuals who are not yet adults
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 |
|---|---|---|
| Pleural gas analysisPatients enrolled in this study will undergo both VI and pleural gas analysis to assess for air leak following surgical chest tube placement. For pleural gas analysis, an outlet gas analyzer will be kept on the outlet port of the chest drain for the entire duration of time that a chest tube is in place. We plan to collect both continuous data, looking for intermittent spikes and gas changes, along with episodic data collected during specific air leak assessments. The gas analyzer may better be able to measure an air leak during these specific procedures conducted twice per day, but it will also be used at the outlet port of the chest drain the rest of the time to continuously check for an air leak throughout the hospital stay. | Device | – |
Primary outcome
Accuracy alone
Time frame: One year
Whether gas analysis can accurately assess for air leak
1 secondary outcome
Using VI as well
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural gas analysis in people with Air Leak From Lung and Pneumothorax, run by Lung Healing Technologies Inc 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Dodd (3033242264, ddodd@lunghealingtechnologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy alone (time frame: One year). 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 9 Sep 2025.