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Mini Bronchoalveolar Lavage for Lung Injury

N/A
Recruiting
Research Sponsored by WilliamJanssen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days on ventilator 1-2, 4-6 and 8-10
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how white blood cells respond to lung inflammation in people with ARDS and how testing lung cells can help reduce the time to start treatment for ventilator-associated pneumonia. Participants will receive oxygen, have small amounts of fluid taken from their lungs, and have nasal and blood samples taken.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include discomfort during the miniBAL procedure and risks associated with pre-oxygenation and fluid introduction into the lungs such as temporary oxygen level changes. Blood draws might cause bruising or infection at the needle site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days on ventilator 1-2, 4-6 and 8-10
This trial's timeline: 3 weeks for screening, Varies for treatment, and days on ventilator 1-2, 4-6 and 8-10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate host response to ARDS
Macrophage signaling
Recruited versus resident macrophages
+1 more
Secondary study objectives
Ventilator associated pneumonia (VAP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study Population GroupExperimental Treatment1 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)

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,275 Total Patients Enrolled
WilliamJanssenLead Sponsor

Media Library

Study Population Group Clinical Trial Eligibility Overview. Trial Name: NCT05767671 — N/A
Bacterial Pneumonia Research Study Groups: Study Population Group
Bacterial Pneumonia Clinical Trial 2023: Study Population Group Highlights & Side Effects. Trial Name: NCT05767671 — N/A
Study Population Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05767671 — N/A
~8 spots leftby Sep 2025