Aerosol Glycerine System for Detecting Lung Air Leaks

(CT0136 Trial)

Overseen By Moishe Liberman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Healthy individuals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). However, the standard used to detect and localize the air leaks, the submersion test, is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery. Considering the prevalence of this complication and the absence of a surgical standard of care for such complications, the aim of this study is to develop a system to create and send a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Aerosol Glycerine System for detecting lung air leaks?

The effectiveness of aerosol delivery systems, like the Aerosol Glycerine System, is supported by studies showing that similar systems can efficiently deliver medication to the lungs, as seen with the eFlow Closed System nebulizer used for COPD treatment. Additionally, the use of glycerol-based compounds has been shown to enhance mucus clearance in patients with chronic bronchitis, suggesting potential benefits in detecting lung air leaks. ^{1 2 3 4 5}

Is the Aerosol Glycerine System safe for humans?

There are reports of adverse health effects like respiratory irritation and asthma from glycol-based aerosols used in theatrical smokes, which are similar to the Aerosol Glycerine System. Additionally, studies on glycerol combustion in rats showed harmful effects on the respiratory system, suggesting potential safety concerns for humans. ^{6 7 8 9 10}

How does the Aerosol Glycerine System treatment for detecting lung air leaks differ from other treatments?

The Aerosol Glycerine System is unique because it uses glycerine in aerosol form to detect lung air leaks, which is different from traditional methods that may not use aerosolized substances. This approach leverages the properties of glycerine to potentially provide a more precise and non-invasive way to identify leaks in the lungs. ^{6 8 11 12 13}

Eligibility Criteria

This trial is for patients undergoing lung transplant surgery or those who are organ donors but ineligible to donate their lungs. Healthy individuals cannot participate.

Inclusion Criteria

I am scheduled for a lung transplant surgery.

I cannot donate my lungs.

Exclusion Criteria

Healthy individuals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Procedure

Development and validation of a system using aerosol glycerine to detect and localize intraoperatively pulmonary air leaks on ex-vivo human lungs.

48 months

Follow-up

Participants are monitored for safety and effectiveness after the experimental procedure

4 weeks

Treatment Details

Interventions

• Aerosol Glycerine System

Trial Overview The study is testing a new system that uses aerosol glycerine smoke to detect and localize air leaks during lung surgery, which could improve postoperative outcomes and reduce hospital stays.

Participant Groups

Group I: Air Leaks Experimental Treatment 1 Intervention

Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

In a study involving 15 patients with stable chronic bronchitis, treatment with iodopropylidene glycerol (IPG) did not significantly improve tracheobronchial clearance (TBC) for the entire group, but it did enhance TBC in 6 patients who were able to expectorate during the observation periods.

The results suggest that IPG can be an effective expectorant, particularly for patients with high mucus production, as a positive correlation was found between sputum production and improvement in TBC after IPG treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of iodopropylidene glycerol on tracheobronchial clearance in stable, chronic bronchitic patients. Pavia, D., Agnew, JE., Glassman, JM., et al.[2015]

Recent advancements in aerosol delivery methods, such as spacers and breath-actuated inhalers, have improved the efficiency of medication delivery to the lungs, which is crucial for maximizing therapeutic benefits while minimizing side effects.

There is a lack of comprehensive information from manufacturers about the aerosol characteristics of their devices, which is essential for clinicians to make informed decisions when selecting the best delivery systems for their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing delivery methods for obstructive lung diseases. Dolovich, M.[2019]

In a study of 66 patients with chronic obstructive pulmonary disease (COPD), 90.9% reported being satisfied or very satisfied with the eFlow nebulizer, indicating high device satisfaction in real-world use.

Among those who had previously used other nebulizers, 80% felt more satisfied with the eFlow, highlighting its ease of use and effectiveness in administering glycopyrrolate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational Real-World Study to Assess Clinical Characteristics and Device Satisfaction in Patients with COPD Treated with Glycopyrrolate/eFlow® CS. Stephenson, JJ., Dembek, C., Caldwell-Tarr, A., et al.[2022]

The eFlow® Closed System nebulizer effectively delivers glycopyrrolate for COPD treatment, achieving a high delivered dose of 88% of the nominal dose and a short nebulization time of 1-2.5 minutes.

The aerosol produced has a fine particle fraction of 72% and a mean mass median aerodynamic diameter of 3.7 μm, which is optimal for targeting both central and peripheral airways, ensuring effective lung deposition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Characterization of the eFlow Closed System Nebulizer with Glycopyrrolate Inhalation Solution. Pham, S., Ferguson, GT., Kerwin, E., et al.[2019]

The AERx Pulmonary Delivery System demonstrated superior lung deposition efficiency, with 53.3% of the aerosol reaching the lungs compared to only 21.7% from the metered dose inhaler (MDI), indicating its potential for more effective pulmonary drug delivery.

The AERx system also showed a more consistent and homogeneous distribution of aerosol in the lungs, making it a promising option for delivering medications that need to act systemically through the lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of in vitro and in vivo efficiencies of a novel unit-dose liquid aerosol generator and a pressurized metered dose inhaler. Farr, SJ., Warren, SJ., Lloyd, P., et al.[2019]

A new sampling and analytical method was developed to effectively collect and analyze aerosolized glycols used in theatrical smoke production, addressing previous inconsistencies in measurement.

The method demonstrated high desorption efficiencies (over 90%) for various glycol compounds and established detection limits, contributing to improved assessment of workplace exposure to potentially harmful substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of glycols in air: development of sampling and analytical methodology and application to theatrical smokes. Pendergrass, SM.[2009]

Exposure to exhaust gases from glycerol combustion caused significant harm to the respiratory system of rats, as evidenced by changes in respiratory mechanics and histological analysis over a 13-week period.

The study found that the combustion gases led to narrower airways and increased airway resistance, indicating that these gases can negatively impact lung function and tissue properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in rat respiratory system produced by exposure to exhaust gases of combustion of glycerol. Serra, DS., Evangelista, JSAM., Zin, WA., et al.[2018]

Three different methods for measuring glycerin in allergenic extracts and diagnostic antigens were tested, showing that all methods are valid for most product types examined.

The liquid chromatographic method and gas chromatographic method demonstrated high accuracy with recoveries between 95.0% and 101.4%, and low variability (coefficients of variation of 2.2% or less), making them reliable for glycerin quantification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas chromatographic, liquid chromatographic, and titrimetric procedures for determination of glycerin in allergenic extracts and diagnostic antigens: comparative study. Del Grosso, AV., May, JC.[2013]

Experimental cigarettes using a glycerol-containing tobacco-substitute sheet reduced the yields of most harmful smoke constituents, leading to a significant decrease in human exposure to nicotine by an average of 18% and smoke particulates by 29%.

While the approach shows promise in reducing exposure to certain toxicants, challenges remain with some smoke components and the overall sensory experience of smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a novel tobacco-substitute sheet and smoke dilution to reduce toxicant yields in cigarette smoke. McAdam, KG., Gregg, EO., Liu, C., et al.[2023]

This study reveals that e-cigarettes produce a wider variety of chemical compounds from propylene glycol (PG) and glycerol (GLY) than previously reported, highlighting the need for more comprehensive research on e-cigarette emissions.

The research identifies specific molecular pathways and chemical conditions that enhance the reactivity of PG and GLY, which could lead to the formation of potentially harmful byproducts during vaping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solvent Chemistry in the Electronic Cigarette Reaction Vessel. Jensen, RP., Strongin, RM., Peyton, DH.[2022]

The study found that the propylene glycol (PG) to glycerol (GL) ratios in e-liquids remained consistent before and after aerosolization, indicating that the composition does not significantly change during vaping.

Maintaining the PG:GL ratio is crucial because substantial changes in e-liquid composition could affect the aerosol profile, which may influence the vaping experience and health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ratio of Propylene Glycol to Glycerol in E-Cigarette Reservoirs Is Unchanged by Vaping As Determined by 1H NMR Spectroscopy. Kerber, PJ., Duell, AK., Peyton, DH.[2021]

The newly developed device can automatically maintain specific concentrations of triethylene or propylene glycol vapor in the air, which is important for studying their effects on airborne infections.

Additionally, the device allows for rapid measurement of glycol content in the air, enhancing the ability to test the efficacy of glycol vapors in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A DEVICE FOR AUTOMATICALLY CONTROLLING THE CONCENTRATION OF GLYCOL VAPORS IN THE AIR. Puck, TT., Wise, H., Robertson, OH.[2021]

The study developed a reliable method for quantitatively determining sorbitol and glycerol in pharmaceutical and personal care products, using two complementary detection techniques: an evaporative light scattering detector and an ultraviolet-visible detector.

This new method is stability-indicating, reproducible, and sensitive, offering better detection sensitivity for sorbitol and comparable sensitivity for glycerol compared to previous methods that used refractive index detectors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An isocratic HPLC method for the determination of sorbitol and glycerol in pharmaceutical formulations. Simonzadeh, N., Ronsen, B.[2013]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Effects of iodopropylidene glycerol on tracheobronchial clearance in stable, chronic bronchitic patients. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Changing delivery methods for obstructive lung diseases. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Observational Real-World Study to Assess Clinical Characteristics and Device Satisfaction in Patients with COPD Treated with Glycopyrrolate/eFlow® CS. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

In Vitro Characterization of the eFlow Closed System Nebulizer with Glycopyrrolate Inhalation Solution. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of in vitro and in vivo efficiencies of a novel unit-dose liquid aerosol generator and a pressurized metered dose inhaler. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Determination of glycols in air: development of sampling and analytical methodology and application to theatrical smokes. [2009]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in rat respiratory system produced by exposure to exhaust gases of combustion of glycerol. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Gas chromatographic, liquid chromatographic, and titrimetric procedures for determination of glycerin in allergenic extracts and diagnostic antigens: comparative study. [2013]

9. England pubmed.ncbi.nlm.nih.gov

The use of a novel tobacco-substitute sheet and smoke dilution to reduce toxicant yields in cigarette smoke. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Solvent Chemistry in the Electronic Cigarette Reaction Vessel. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Ratio of Propylene Glycol to Glycerol in E-Cigarette Reservoirs Is Unchanged by Vaping As Determined by 1H NMR Spectroscopy. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A DEVICE FOR AUTOMATICALLY CONTROLLING THE CONCENTRATION OF GLYCOL VAPORS IN THE AIR. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

An isocratic HPLC method for the determination of sorbitol and glycerol in pharmaceutical formulations. [2013]