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Disqualifiers: Protocol deviation, Non-compliance, Adverse event, Consent withdrawn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

44 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Leak-free bronchoscope adapter for lung disease?

The research on endobronchial one-way valves, which are similar to the leak-free bronchoscope adapter, shows that they can effectively stop persistent air leaks in the lungs, especially in patients who cannot undergo surgery. This suggests that the leak-free bronchoscope adapter might also help manage air leaks in a minimally invasive way. ^{1 2 3 4 5}

Is the Leak-Free Bronchoscope Adapter safe for use in humans?

The research articles do not provide specific safety data for the Leak-Free Bronchoscope Adapter, but they do discuss the safety of bronchoscopy procedures in general. Bronchoscopy is generally considered safe, though some adverse events like chest pain, shortness of breath, and fever can occur, especially when combined with other procedures like bronchoalveolar lavage. ^{6 7 8 9 10}

How is the leak-free bronchoscope adapter treatment different from other treatments for lung disease?

The leak-free bronchoscope adapter is unique because it reduces gas flow resistance during bronchoscopy, enhancing safety by maintaining a sealed system with a special silicone diaphragm. This design allows for a more efficient and safer procedure compared to traditional methods. ^{4 11 12 13 14}

What is the purpose of this trial?

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 operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.

Research Team

Katherine Su, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Successful treatment of persistent postoperative air leaks following the placement of an endobronchial one-way valve. [2016]

2. Japan pubmed.ncbi.nlm.nih.gov

Bronchoscopic treatment of complex persistent air leaks with endobronchial one-way valves. [2022]

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

Management of Prolonged Pulmonary Air Leaks With Endobronchial Valve Placement. [2020]

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

Special new low resistance to flow tube and endotracheal tube adapter for use during fiberoptic bronchoscopy. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

A prospective randomized study to assess the efficacy of a surgical sealant to treat air leaks in lung surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adult and paediatric size bronchoscopes for bronchoalveolar lavage in mechanically ventilated patients: yield and side effects. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Prevention of droplet dispersal with 'e-mask': A new daily use endoscopic mask during bronchoscopy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Automatic flow interruption bronchoscope: a laboratory study. [2019]

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

Comparison of breathing tube connectors during invasive bronchial procedures. [2018]

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

Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. [2013]

11. China pubmed.ncbi.nlm.nih.gov

[Current Status and Development of Interventional Techniques for Pulmonary Diseases]. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Bronchoscopy in the Diagnosis and Treatment of Post-Operative Lung Complications. [2021]

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

Advances in pediatric flexible bronchoscopy. [2004]

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

Flexible fiberoptic bronchoscopy. [2008]