Serial Lavage and Drainage for Punctured Lung

(HTXDLYLAVGE Trial)

Overseen By Phillp Kemp Bohan, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 15, Prisoner, Pregnant, others

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

Compensation: Varies

Number of Visits: 24

Duration: 72 hours

20 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

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

What data supports the effectiveness of the treatment Serial Lavage and Drainage for a punctured lung?

Research on similar treatments, like continuous pleural lavage, shows it can reduce complications after lung surgery, and studies on drainage methods for lung abscesses indicate they can be effective in treating lung conditions. ^{1 2 3 4 5}

Is Serial Lavage and Drainage generally safe for humans?

Research on similar procedures like bronchoalveolar lavage and whole lung lavage suggests they are generally safe, but there can be risks, especially in critically ill or mechanically ventilated patients. Potential side effects include changes in lung function, low oxygen levels, or symptoms similar to infection. ^{6 7 8 9 10}

How does the treatment Serial Lavage and Drainage for a punctured lung differ from other treatments?

Serial Lavage and Drainage is unique because it involves repeatedly washing out the lung to remove unwanted material, which can improve lung function. This method is similar to techniques used for other lung conditions, like pulmonary alveolar proteinosis, where whole-lung lavage has been shown to be safe and effective. ^{11 12 13 14 15}

What is the purpose of this trial?

This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Research Team

Jeremy Cannon, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for stable trauma patients who have an acute hemothorax (blood in the chest from a punctured or collapsed lung) and need a chest tube. Specific details about inclusion and exclusion criteria are not provided, but typically participants must meet certain health standards to be eligible.

Inclusion Criteria

Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)

I have a significant amount of bleeding in my chest, confirmed by a CT scan.

Able to provide consent for the research study

Exclusion Criteria

I am under 15 years old.

I have had a thoracentesis or pleurodesis without needing ongoing drainage.

Prisoner

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a 28Fr or 14Fr chest tube with daily lavage and drainage

72 hours

Daily visits for lavage at 24h and 48h post-placement

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hemothorax volume and complications

Through hospital discharge or 30 days

Extension

Participants may be monitored for additional interventions and patient-reported outcomes

Long-term follow-up through discharge or 30 days

Treatment Details

Interventions

• Serial Lavage and Drainage

Trial Overview The study is testing whether different sizes of chest tubes (28Fr vs. 14Fr) affect recovery when used with daily lavage (washing out) for draining blood in the chest after trauma. It will measure how much blood is removed, any complications, other treatments needed, hospital stay length, how long the tube stays in, healthcare provider opinions, and patient feelings.

Participant Groups

Group I: Percutaneous 14-Fr Catheter with Daily Lavage and Drainage Experimental Treatment 3 Interventions

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Group II: Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage Experimental Treatment 3 Interventions

Open Tube Thoracostomy with Daily Lavage and Drainage

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

CLR Medical

Collaborator

Findings from Research

In a study of 9 patients with post-surgical thoracic empyema, antibiotics amoxicillin and vancomycin showed good diffusion into the pleural cavity, with pleural concentrations often higher than those in the plasma.

The treatment was effective, with 8 out of 9 patients experiencing a cure of their pleural infection, indicating that these antibiotics can be effective in managing post-surgical empyema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pleural diffusion of amoxicillin 1 and vancomycin in patients treated for post-surgical empyema]. Stern, JB., Péan, Y., Girard, P., et al.[2019]

In a study involving 14 patients with acute lung injury or ARDS, nonbronchoscopic lavage was found to cause less significant changes in heart rate and blood pressure compared to bronchoscopic lavage, suggesting it may be a safer option for certain patients.

Bronchoscopic lavage resulted in a greater reduction in minute ventilation and an increase in carbon dioxide levels compared to nonbronchoscopic lavage, indicating that nonbronchoscopic methods may be less physiologically stressful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of nonbronchoscopic lavage in ARDS. Perkins, GD., Chatterjee, S., Giles, S., et al.[2022]

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]

References

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

Comparative effectiveness of pleural drainage procedures for the treatment of complicated pneumonia in childhood. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Improvement of the transthoracic method of puncture sanitation in complex treatment of lung abscess]. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

Continuous pleural lavage may decrease postoperative morbidity in patients undergoing thoracotomy for stage 2 thoracic empyema. [2010]

4. Japan pubmed.ncbi.nlm.nih.gov

Bilateral pneumothorax: a retrospective analysis of 40 patients. [2006]

5. France pubmed.ncbi.nlm.nih.gov

[Pleural diffusion of amoxicillin 1 and vancomycin in patients treated for post-surgical empyema]. [2019]

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

Safety and tolerability of nonbronchoscopic lavage in ARDS. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Whole lung lavage. [2019]

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

Safety of bronchoalveolar lavage in the critically ill, mechanically ventilated patient. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Risks and side effects of diagnostic bronchoalveolar lavage in ventilated patients]. [2015]

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

[Bilateral sequential whole lung lavage in the same treatment session for pulmonary alveolar proteinosis]. [2014]

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

Alveolar proteinosis. Lobar lavage by fiberoptic bronchoscopic technique. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical and physiological effect of whole-lung lavage in pulmonary alveolar proteinosis: a ten-year experience. [2022]

14. Spain pubmed.ncbi.nlm.nih.gov

[Bilateral bronchoalveolar lavage: a clinical case, method and discussion]. [2019]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical evaluation of bronchopulmonary lavage using the flexible fiberoptic bronchoscope. [2019]