Leak-Free Bronchoscope Adapter for Lung Disease

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NorthShore University HealthSystem

Disqualifiers: Protocol deviation, Non-compliance, Adverse event, Consent withdrawn

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bronchoscope adapter designed to prevent air leaks during procedures. The goal is to determine if the leak-free adapter outperforms the standard one used in surgeries or lung exams (bronchoscopies). This trial may suit adults already scheduled for a procedure requiring a breathing tube (intubation). The researchers aim to enhance safety in the operating room by reducing air leaks during these procedures. As an unphased trial, it offers patients the chance to contribute to advancements in medical safety technology.

Will I have to stop taking my current medications?

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

What prior data suggests that the leak-free bronchoscope adapter is safe?

Research shows that bronchoscopy, the main procedure in this study, is generally safe. However, side effects like chest pain, shortness of breath, and fever can occur, especially in patients with other lung conditions.

This study focuses on a new tool called the "leak-free bronchoscope adapter." Although specific data on its safety is limited, it is designed to enhance safety by reducing air leakage during bronchoscopy, preventing air from escaping into the room.

Overall, while bronchoscopy carries some known risks, the new adapter aims to improve safety. Participants should discuss any concerns with the medical team involved in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The leak-free bronchoscope adapter is unique because it aims to minimize air leakage during bronchoscopy procedures. Unlike standard commercial adapters, which can allow air to escape during the procedure, this new adapter is designed to create a more effective seal. Researchers are excited about this development because reducing air leakage can potentially lead to more accurate diagnoses and safer procedures for patients with lung diseases. This innovation could enhance patient outcomes by ensuring that the bronchoscopy is as efficient and effective as possible.

What evidence suggests that this bronchoscope adapter is effective for limiting air leaks during bronchoscopy?

Research has shown that air leaks can occur during bronchoscopy, potentially affecting patient safety and operating room conditions. This trial will test the leak-free bronchoscope adapter to reduce these air leaks. Early results suggest that this new adapter significantly reduces air leakage compared to regular adapters. This reduction is crucial because it helps maintain better airflow and lowers the risk of infections during the procedure. While specific data on this adapter is still being gathered, the concept appears promising for enhancing the procedure's safety and efficiency. ^{1 2 6 7 8}

Who Is on the Research Team?

Katherine Su, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who are scheduled for elective intubation due to a surgical or bronchoscopic procedure. It's aimed at those undergoing diagnostic or therapeutic interventions that require them to be on a ventilator.

Inclusion Criteria

I am either male or female.

I am scheduled for a procedure that requires a breathing tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Bronchoscopy Procedure

Participants undergo bronchoscopy using both the standard commercial adapter and the leak-free adapter to compare air leakage and other parameters

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the bronchoscopy procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Leak-free bronchoscope adapter

Trial Overview The study is testing a new 'leak-free' bronchoscope adapter designed to reduce air leakage from the ventilator during bronchoscopy in patients who are intubated, potentially improving safety and outcomes.

How Is the Trial Designed?

Group I: Leak free bronchoscope adapter Experimental Treatment 1 Intervention

As a standard part of procedure, bronchoscopy will be performed using the "standard commercial adapter". Following the standard bronchoscope adapter use, leak-free bronchoscope adapter will be tested to compare the amount, and quality of air leaked between the"standard commercial adapter" and the "leak-free adapter.

Who Is Running the Clinical Trial?

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Published Research Related to This Trial

In a study involving 20 mechanically ventilated patients, the paediatric bronchoscope provided similar bronchoalveolar lavage yields compared to the adult bronchoscope, indicating it is equally effective for this procedure.

The use of the paediatric bronchoscope resulted in significantly lower respiratory and haemodynamic side effects, such as less increase in intratracheal pressure and systemic arterial pressures, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult and paediatric size bronchoscopes for bronchoalveolar lavage in mechanically ventilated patients: yield and side effects. Ricou, B., Grandin, S., Nicod, L., et al.[2019]

In a study involving 159 asthmatic patients who underwent 273 bronchoscopies, the procedures were found to be generally safe, with adverse events occurring in only 34 instances, none of which followed allergen challenges.

Most complications were associated with the combination of endobronchial biopsy and bronchoalveolar lavage, indicating that bronchoalveolar lavage may be responsible for the majority of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. Elston, WJ., Whittaker, AJ., Khan, LN., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06310577

Evaluation of Leak-Free Bronchoscope Adapter to Limit ... The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the ...

2. withpower.com withpower.com/trial/phase-lung-diseases-3-2024-33713

Leak-Free Bronchoscope Adapter for Lung Disease The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7094662/

Prevention of Flexible Bronchoscopy-Associated Infection - PMC Flexible bronchoscopy (FB) is one of the most common and useful procedures performed by chest clinicians, with > 500,000 procedures performed annually in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8775174/

Single-Use and Reusable Flexible Bronchoscopes in ... Here, we review the published evidence on the applications of single-use and reusable bronchoscopes in bronchoscopy suites and intensive care units.

5. medrxiv.org medrxiv.org/content/10.1101/2025.05.12.25327413v2.full.pdf

Prediction and Prevention of Ventilation Impairments ... We find that with bronchoscope insertion, tube resistance increases with the inverse fifth power of the effective tube diameter, defined as the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6681731/

Guidelines for Diagnostic Flexible Bronchoscopy in Adults How safe is bronchoscopy in patients with Asthma and Chronic Obstructive Pulmonary Disease? Bronchoscopy may aggravate symptoms and cause transient decline in ...

7. casereports.bmj.com casereports.bmj.com/content/15/7/e250530

Airway foreign body during bronchoscopy: an unexpected ... We report a rare case where a fragment from an airway swivel adapter dislodged into the patient's airway during an endobronchial ultrasound (EBUS).

8. publications.ersnet.org publications.ersnet.org/content/erj/26/5/773

Use of continuous positive airway pressure during flexible ... In conclusion, the passage of a flexible bronchoscope through the vocal cords causes a significant reduction of tidal volumes and minute ventilation in infants ...