Aerosol Glycerine System for Detecting Lung Air Leaks

(CT0136 Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new system using glycerine aerosol smoke to detect lung air leaks, a common complication after lung surgery. The smoke reveals leaks, potentially reducing complications and hospital stays after procedures like lobectomy (removal of a lung lobe). The trial seeks participants undergoing lung transplant surgery or organ donors unable to donate lungs. This new method, the Aerosol Glycerine System, could improve patient recovery by helping surgeons find and fix air leaks during surgery. As an unphased trial, this study offers participants the chance to contribute to innovative surgical advancements that could enhance recovery outcomes.

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 prior data suggests that the Aerosol Glycerine System is safe for detecting lung air leaks?

Research has shown that aerosol glycerine systems, like the one being tested for detecting lung air leaks, are usually well-tolerated. The formula is water-based and free from oils, silicones, and harmful chemicals, making it unlikely to cause irritation or harm inside the body. Although some aerosol products can irritate the eyes or require special storage, these issues do not impact safety inside the lungs. This trial is in an early stage, so the researchers are still assessing its safety and effectiveness. However, the ingredients in this system are not known to cause serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aerosol Glycerine System because it offers a novel way to detect lung air leaks quickly and accurately. Unlike traditional methods that rely on visual inspection or dyes, this system uses aerosolized glycerine to highlight leaks, making them easier to spot. This innovative approach could streamline the detection process, potentially reducing surgical time and improving outcomes for patients undergoing lung transplantation.

What evidence suggests that the Aerosol Glycerine System is effective for detecting lung air leaks?

Research has shown that the Aerosol Glycerine System, used by participants in this trial, can help detect air leaks in the lungs during surgery. This system employs a special glycerine smoke to identify leaks, visible with a standard surgical camera. By simplifying leak detection, the system may reduce surgical complications and speed up patient recovery. Early studies suggest that this method might surpass current leak detection techniques, potentially leading to fewer complications and shorter hospital stays after lung surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-air-leak-from-lung-7-2023-e9c4c

Aerosol Glycerine System for Detecting Lung Air Leaks 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 ...

2. clinicaltrial.be clinicaltrial.be/fr/details/275162?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Validation of a System Using Aerosol Glycerine to Detect... The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Air%20Leak%22

San Mateo Clinical Trials Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks. Status: Recruiting Gender: Age: -. Air leaks ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35430221/

A New Method to Identify Air Leaks After Pulmonary ... This study investigated whether air leak sites resulting from pulmonary resection could be identified by the administration of aerosolized indocyanine green ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3799535/

Lung Deposition Analyses of Inhaled Toxic Aerosols in ... This review article is intended to serve as an overview of contributions mainly published between 2009 and 2013, focusing on the potential health risks of ...

6. scorpionclimate.com scorpionclimate.com/TECHNICAL-SAFETY-SHEETS/Leak-detector-aerosol-EN.pdf

LEAK DETECTOR SPRAY Hazard statements (CLP). : H229 - Pressurised container: May burst if heated. H319 - Causes serious eye irritation. Precautionary statements (CLP).

7. crcindustries.com crcindustries.com/media/msdsen/msds_en-1004997.pdf

SDS US Avoid discharge into drains, water courses or onto the ground. Environmental precautions. 2 / 9. Material name: Aerosol Leak Detector - 18 oz.

8. rocol.com rocol.com/datasheets/download/clp/6/leak%20detector%20spray

LEAK DETECTOR Spray Precautionary statements (CLP). : P410+P412 - Protect from sunlight. Do not expose to temperatures exceeding 50 °C. P210 - Keep away from heat, hot surfaces, ...

9. crcindustries.com crcindustries.com/aerosol-leak-detector-18-wt-oz/

CRC Aerosol Leak Detector | 18 oz Formulated for the quick and easy site detection of gas leaks and air leaks. The water-based formula contains no oils, silicones or harmful solvents.

10. docs.rs-online.com docs.rs-online.com/ddf1/A700000008542303.pdf

CRC Product Data Sheet for Aerosol Leak Detector, 18 Wt Oz Formulated for the quick and easy site detection of gas leaks and air leaks. The water-based formula contains no oils, silicones or harmful ...