Mini Bronchoalveolar Lavage for Lung Injury

Overseen By William Janssen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: WilliamJanssen

Disqualifiers: Transplantation, Hemoptysis, Bleeding risk, others

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

Compensation: Varies

Number of Visits: 3

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how the immune system, particularly macrophages, responds to lung injuries and inflammation in patients with Acute Respiratory Distress Syndrome (ARDS). Researchers aim to understand how these cells control inflammation and how their roles differ from other immune cells. The study also seeks to determine if frequent testing, such as the Non-Bronchoscopic Mini Bronchoalveolar Lavage (a procedure for collecting lung samples), can accelerate treatment for lung infections in ventilated patients. Individuals in the ICU on mechanical ventilators due to ARDS or similar conditions may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to foundational research that could lead to faster and more effective treatments for ARDS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.

What prior data suggests that this mini bronchoalveolar lavage is safe for patients on mechanical ventilation?

Research has shown that Non-Bronchoscopic Mini Bronchoalveolar Lavage (mini-BAL) safely studies lung conditions. Studies have found that patients, even very young ones with serious lung problems, tolerate this procedure well. It has been safely used to help diagnose lung infections in newborns, including those born prematurely.

The procedure involves using a small amount of saline (a saltwater solution) to wash a part of the lung, which is then tested. This method doesn't use a camera or scope, making it less invasive. Consequently, reports of problems or side effects are few. This suggests that mini-BAL is a reliable and safe option for assessing lung health in patients with conditions like Acute Respiratory Distress Syndrome (ARDS). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mini bronchoalveolar lavage procedure because it offers a less invasive way to manage lung injuries in patients on mechanical ventilation. Unlike traditional bronchoalveolar lavage, which requires a bronchoscope, this mini version is non-bronchoscopic, meaning it can be performed more easily and with fewer resources. This could potentially lead to quicker, safer assessments of lung conditions, allowing for faster and more targeted treatment decisions in the ICU setting.

What evidence suggests that this Mini Bronchoalveolar Lavage is effective for lung injury?

Research has shown that non-bronchoscopic mini bronchoalveolar lavage can help study lung infections and inflammation. In one study, researchers used this technique to collect samples from patients with sudden lung injury, effectively identifying infections like pneumonia. Another study found it to be an easy and useful way to diagnose ventilator-associated pneumonia (VAP), enabling quicker treatment. This method allows doctors to collect lung fluid without a bronchoscope, a long, flexible tube typically used for this purpose. These findings suggest that this method could improve lung condition management by providing faster diagnosis and treatment. Participants in this trial will undergo non-bronchoscopic mini bronchoalveolar lavage to further evaluate its effectiveness in managing lung conditions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for ICU patients on mechanical ventilation due to ARDS or similar conditions, expected to remain ventilated for at least 48 hours. It's not suitable for those with chronic lung diseases, recent immunosuppressant use, history of organ transplant, severe bleeding risks, a directive against life-sustaining treatment, morbid state with less than 14 days survival expectancy or pregnancy.

Inclusion Criteria

I have given, or my legal representative has given, written consent for the study.

I have been admitted to the intensive care unit.

I am currently intubated or will be within the next 48 hours.

Exclusion Criteria

Presence of pneumomediastinum or pneumothorax on recent imaging

Presence of an advanced directive with Do Not Intubate (DNI) status (Do Not Resuscitate (DNR) is acceptable)

I have had a solid organ or bone marrow transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Observation

Participants undergo procedures to collect lung fluid and nasal brushings for analysis of macrophage activity and bacterial presence.

10 days

3 procedures (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the observational procedures, including a potential follow-up phone call.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-Bronchoscopic Mini Bronchoalveolar Lavage

Trial Overview

The study observes how white blood cells in the lungs respond to inflammation from ARDS. Participants undergo non-bronchoscopic mini bronchoalveolar lavage (miniBAL) where saline is introduced and then removed from the lungs via a catheter for analysis. This helps understand immune responses and may expedite pneumonia treatment initiation.

How Is the Trial Designed?

Group I: Study Population Group Experimental Treatment 1 Intervention

People in the ICU on mechanical ventilation due to a diagnosis of ARDS or any other diagnosis that requires mechanical ventilation (following surgery, sepsis without lung involvement, seizures)

Who Is Running the Clinical Trial?

WilliamJanssen

Lead Sponsor

Trials

1

Recruited

60+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Non-bronchoscopic bronchoalveolar lavage (NB-BAL) is generally safe and well-tolerated in critically ill mechanically ventilated children, with only 7% experiencing significant immediate complications that required increased support.

While there was no overall significant change in oxygenation index (OI) after the procedure, some patients did experience temporary increases in OI, particularly those with baseline OIs greater than 20, indicating the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe is non-bronchoscopic bronchoalveolar lavage in critically ill mechanically ventilated children? Burmester, M., Mok, Q.[2020]

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]

Saline instillation followed by suctioning in healthy piglets significantly increased the opening pressures of the lungs, indicating a change in lung mechanics that could affect ventilation.

Despite a significant decrease in arterial oxygen levels after the procedure, the values remained within the high normal range, suggesting that while there are effects on lung function, they may be manageable with appropriate recruitment maneuvers and PEEP (positive end-expiratory pressure).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflation lung mechanics deteriorates markedly after saline instillation and open endotracheal suctioning in mechanically ventilated healthy piglets. Cunha-Goncalves, D., Perez-de-Sá, V., Ingimarsson, J., et al.[2015]

This study is the first to provide data on bronchoalveolar lavage in healthy South African children, revealing that alveolar macrophages are the main cell type present, while those with inflammatory lung conditions showed increased neutrophils.

Exogenous pulmonary surfactant exposure significantly reduced inflammatory cytokines and increased anti-inflammatory cytokines (IL-10 and IL-12), suggesting that surfactant treatment could be beneficial in reducing inflammation in respiratory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exogenous surfactant on Paediatric Bronchoalveolar lavage derived macrophages' cytokine secretion. van Rensburg, L., van Zyl, JM., Smith, J., et al.[2020]

A new nonbronchoscopic bronchoalveolar lavage technique using a sterile feeding tube was successfully performed on 15 intubated infants, allowing for effective diagnosis of pulmonary infections without the complications associated with traditional bronchoscopy.

This method resulted in a specific diagnosis for 60% of the patients and showed radiographic improvement in two cases, demonstrating its safety and clinical utility in treating respiratory failure in small infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonbronchoscopic bronchoalveolar lavage in mechanically ventilated infants: technique, efficacy, and applications. Koumbourlis, AC., Kurland, G.[2019]

Nonbronchoscopic bronchoalveolar lavage (NB-BAL) is a safe procedure for diagnosing ventilator-associated pneumonia (VAP) in preterm neonates, with only minor transient complications observed in 19.5% of cases and no significant adverse effects on respiratory or cardiopulmonary function.

In a study of 31 neonates, NB-BAL successfully diagnosed VAP in 69.6% of cases, allowing for targeted antibiotic treatment in over half of the patients, highlighting its clinical utility in the NICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical application of nonbronchoscopic bronchoalveolar lavage in preterm neonates with clinical ventilator-associated pneumonia. Liao, CC., Tsai, MH., Lai, SH., et al.[2021]

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]

A new method using a 4F balloon wedge pressure catheter allows for bronchoalveolar lavage (BAL) in children with small artificial airways, making it possible to sample alveolar contents without needing a larger bronchoscope.

In a study of 20 children aged 1 month to 6.5 years, this nonbronchoscopic BAL technique successfully provided valuable clinical information in 85% of cases, avoiding the need for open lung biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonbronchoscopic approach to bronchoalveolar lavage in children with artificial airways. Alpert, BE., O'Sullivan, BP., Panitch, HB.[2019]

Bronchoalveolar lavage (BAL) significantly reduced the need for invasive mechanical ventilation in neonates with severe pneumonia, with only 30% requiring it after BAL compared to 70% at admission.

Patients in the BAL group experienced shorter hospital stays (9.2 days) and lower hospital costs (12,557 Yuan) compared to the control group (14.1 days and 19,121 Yuan), with no significant adverse side effects observed during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bronchoalveolar Lavage as Adjunct Therapy in the Treatment of Neonatal Severe Pneumonia: A Prospective Case-Control Study. Liu, J., Zhao, HR., Wei, HL., et al.[2021]

This study provides the first reference values for bronchoalveolar lavage (BAL) in 'normal' Greek children, showing that alveolar macrophages are the predominant cell type in healthy lungs.

In children with inflammatory lung diseases, BAL fluid showed significantly higher levels of neutrophils and cytokines like IL-8 and TNF-alpha, suggesting these measurements could be useful for early detection of lung inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoalveolar lavage in children with inflammatory and non inflammatory lung disease. Gidaris, D., Kanakoudi-Tsakalidou, F., Papakosta, D., et al.[2021]

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Non bronchoscopic BAL is an inexpensive, easy, and useful technique for microbiologic diagnosis of VAP. This finding, if verified, might simplify the approach.

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