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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different chest tube sizes and daily cleaning techniques (irrigations) affect individuals with a punctured lung, specifically those with acute hemothorax (HTX), where blood collects between the lung and chest wall. The study compares two chest tube methods, including the serial lavage and drainage technique, to determine which is more effective for lung healing, recovery time, and patient comfort. Participants should be stable after a traumatic lung injury, have a moderate to large amount of blood in the chest, and require a chest tube for drainage. This trial aims to improve treatments for lung injuries, making recovery safer and more comfortable. As an unphased trial, it offers participants the opportunity to contribute to pioneering research that could enhance future treatment options.

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 prior data suggests that this technique is safe for treating punctured lungs?

Research shows that both open tube thoracostomy and percutaneous catheter methods are commonly used to manage fluid or air in the chest. Studies have found that tube thoracostomy, which involves placing a tube into the chest, is widely used. However, complications such as infection or tube displacement can occur.

Research suggests that the percutaneous catheter is as effective as larger chest tubes for fluid drainage. Major complications are rare, though some patients may experience fluid recurrence or mild pain after the procedure.

In summary, both treatments are generally safe, but like any procedure, they carry some risks. These risks are usually low and similar for both methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new lavage and drainage methods for punctured lungs because they offer innovative approaches to managing the condition. Unlike the standard of care, which typically involves simple tube thoracostomy without daily lavage, these treatments incorporate daily lavage, potentially reducing infection risk and improving lung re-expansion. The Open 28 Fr Tube Thoracostomy provides a larger drainage channel, while the Percutaneous 14-Fr Catheter offers a less invasive option. Both methods aim to enhance recovery outcomes by improving fluid removal and promoting quicker healing.

What evidence suggests that this trial's treatments could be effective for punctured lung?

This trial will compare two methods for treating traumatic hemothorax: an open 28 Fr tube thoracostomy with daily lavage and drainage, and a percutaneous 14-Fr catheter with daily lavage and drainage. Research has shown that both open tube thoracostomy and using a small tube with daily washing and drainage effectively treat traumatic hemothorax, a condition where blood collects in the chest. Studies have found that a small tube, called a 14-Fr percutaneous catheter, performs as well as a larger chest tube in removing blood from the chest. Both methods successfully clear blood and air without causing additional complications. These treatments help the lung expand and improve breathing. Initial findings suggest that daily chest washing can enhance drainage and reduce hospital stays. Overall, both methods are promising options for managing this condition. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeremy Cannon, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10910477/

Percutaneous thoracostomy with thoracic lavage for traumatic ...

This report describes techniques for combining percutaneous thoracostomy with pleural lavage and presents results from a performance improvement series of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8975284/

Comparison of the Therapeutic Effects of a Pigtail Catheter ...

Pigtail catheters might be as effective as chest tubes for treating patients with SP in terms of lung re-expansion.

3.

journals.lww.com

journals.lww.com/journalacs/fulltext/2023/06000/effectiveness_of_single_chest_tube_vs_double_chest.30.aspx

Effectiveness of Single Chest Tube vs Double ...

The placement of a single tube after decortication is effective in reducing drain output, time of drain, and hospital stay.

4.

tamingthesru.com

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Tube Thoracostomy for Hemothorax - Is a Tiny Tube Just ...

A 14-Fr percutaneous catheter (“pigtail”) is equally as effective for drainage of traumatic hemothorax as traditional chest tube.

5.

annemergmed.com

annemergmed.com/article/S0196-0644(07)00725-1/fulltext

Needle Aspiration or Tube Thoracostomy?

The existing evidence indicates that needle aspiration is at least as safe and effective as tube thoracostomy for management of primary spontaneous pneumothorax ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK556088/

Care of a Chest Tube - StatPearls - NCBI Bookshelf

Chest tubes are a critical intervention for managing pleural space pathologies, including pneumothorax, hemothorax, empyema, and postoperative drainage.

7.

jtd.amegroups.org

jtd.amegroups.org/article/view/3133/html

Tube thoracostomy; chest tube implantation and follow up

Tube thoracostomy is the most commonly performed surgical procedure in thoracic surgery. It is defined as insertion of a tube (chest tube) into the pleural ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4093965/

Thoracostomy tubes: A comprehensive review of ...

This review focuses on chest tube complications and related topics, with emphasis on prevention and problem-oriented approaches to diagnosis and treatment.

9.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1155/2012/256878

Tube Thoracostomy: Complications and Its Management

This is an uncommon but fatal complication that can occur following tube thoracostomy for pneumothorax or pleural effusion. Mortality rate ...