56 Participants Needed

Mini Bronchoalveolar Lavage for Lung Injury

OV
WJ
Overseen ByWilliam Janssen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: WilliamJanssen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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).12345

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.12678

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.
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: Study Population GroupExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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).
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]

Citations

Comparison of two non-bronchoscopic methods for ...We designed a prospective study in two groups of patients, those with acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) and those with acute ...
Nonbronchoscopic Bronchoalveolar Lavage Improves ...We designed a pilot study to test respiratory culture accuracy between EA and NBBL. Adult, intubated patients with suspected pneumonia received ...
Mini Bronchoalveolar Lavage for Lung InjuryThis N/A medical study run by WilliamJanssen is evaluating whether Non-Bronchoscopic Mini Bronchoalveolar Lavage will have tolerable side effects & efficacy ...
Research Priorities for Noninvasive Sampling of the Lower ...Research using lower respiratory tract (LRT) sampling may lead to improved understanding and management of patients with acute respiratory failure (ARF).
Comparison between bronchoscopic BAL and non- ...Non bronchoscopic BAL is an inexpensive, easy, and useful technique for microbiologic diagnosis of VAP. This finding, if verified, might simplify the approach.
Proteomic Analysis of Two Non-Bronchoscopic Methods of ...Proteomic Analysis of Two Non-Bronchoscopic Methods of Sampling the Lungs of Patients with the Acute Respiratory Distress Syndrome (ARDS).
Safety and clinical application of nonbronchoscopic ...NB-BAL is a safe and clinically applicable method for determining the etiology and diagnosis of VAP in the NICU, even in extremely preterm neonates with major ...
Non-bronchoscopic bronchoalveolar lavage (mini ... - Thieme ConnectAim The aim of this study is to describe the feasibility and clinical relevance of mini-BAL in critically ill pediatric patients with respiratory failure (pARDS) ...
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