Recruiting

Inflammation in ARDS

Sponsor:

William Janssen, MD

Code:

NCT05767671

Conditions

Acute Respiratory Distress Syndrome

Ventilator Associated Pneumonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Non-Bronchoscopic Mini Bronchoalveolar Lavage

Study Details

Brief summary:

The goal of this observational clinical trial is to learn about the role white blood cells (macrophages) play in lung inflammation in people with Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are:

1. How does the immune system respond to different kinds of lung injury and inflammation and how do those processes differ from each other?
2. What roles do the cells that live in the lungs (macrophages) play in turning off inflammation? How does their role differ from other cells that are called to the lung to help repair injury (recruited macrophages)?
3. Will more frequent testing of lung cell samples help reduce the time it takes to start treatment for ventilator-associated pneumonia (VAP) and therefore reduce the rates of initial therapy failure?

Participants will be in the intensive care unit (ICU) on a mechanical ventilator (machine that helps patients breathe) because they have ARDS or are on a mechanical ventilator for some other reason (control group). The following will happen:

1. Participants will be given 100% oxygen through the breathing machine (mechanical ventilator) for 3-5 minutes. This is called pre-oxygenation.
2. A lung specialist (pulmonologist), a member of Dr. Janssen's research team, or respiratory therapist will place small amount of saline into the lung using a long catheter going through the breathing tube.
3. The fluid will be removed with suction and will be sent to the laboratory for testing.
4. This will be repeated two more times over the course of 10 days, or less if participants are taken off of the ventilator. The procedure will be performed no more than three times.
5. Two nasal brushings will be taken from the participants' nose.
6. Approximately 3 tablespoons of blood will be removed by putting a needle into the participants vein. This is the standard method used to obtain blood for tests. A total of 9 tablespoons will be taken for research purposes over the course of this study
7. Data including the participants age, sex, severity of illness, and other medical conditions will be recorded to determine how these can affect the white blood cells.
8. If bacteria are isolated from the fluid in the participants lung, the participants' physician may choose to place the participants on antibiotics to treat an infection.
9. A follow-up phone call may be made by a member of the research team after discharge from the hospital. At this time, the participant may be invited to participate in the Post-ICU clinic at National Jewish Health.

Conditions

Acute Respiratory Distress Syndrome

Ventilator Associated Pneumonia

Study ID

NCT05767671

Start date

Apr 10, 2020

Status verified date

Feb, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Sep 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent (by LAR if subject unconscious or has altered mental status) prior to any study procedures. Verbal consent may be used as necessary
  • Adults greater than 18 years of age
  • Admission to the intensive care unit.
  • Orally/nasally intubated or expected to be intubated within 48 hours

Exclusion Criteria:

  • History of solid organ or bone marrow transplantation
  • Severe or massive hemoptysis
  • At significant risk for bleeding (INR > 3 or PTT > 3x normal)
  • 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)
  • Morbid state or expected to survive less than 24 hours because of an advanced co-morbid medical condition in the opinion of the PI and/or clinical team and attending physician.
  • Pregnancy

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Study Population Group

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)

Interventions

Non-Bronchoscopic Mini Bronchoalveolar Lavage

A minimally invasive technique frequently used in the ICU to obtain alveolar fluid samples from mechanically ventilated patients. The technique uses a commercially available telescoping catheter with a curved distal tip that allows the operator to direct the catheter into the right or left lung. The catheter is passed through an air-tight adapter on the distal end of the endotracheal tube and gently advanced to the desired lung until resistance is encountered. The inner catheter is then advanced until resistance is again encountered, signifying that the distal catheter tip is "wedged." 20ml of sterile saline is instilled into the catheter followed by 5 ml of air, and the fluid aspirated. Two additional 20ml aliquots of sterile saline are injected and aspirated in a similar fashion. Specimens are pooled and on average provide a combined volume of 10ml.

Primary outcome measure

  • Evaluate host response to ARDS [ Time Frame: Days on ventilator 1-2, 4-6 and 8-10 ]
  • Macrophage signaling [ Time Frame: Days on ventilator 1-2, 4-6 and 8-10 ]
  • Resident alveolar Macrophages [ Time Frame: Days on ventilator 1-2, 4-6 and 8-10 ]
  • Recruited versus resident macrophages [ Time Frame: Days on ventilator 1-2, 4-6 and 8-10 ]

Central Contacts and Locations

Central contacts

Olivia VerBurg

303-398-1201verburgo@njhealth.org

Locations

Intermountain Health - St. Joseph's Hospital - National Jewish Health

Recruiting

Denver, Colorado, United States, 80218

Contacts

Olivia VerBurg

303-398-1201verburgo@njhealth.org

Principal Investigator:

William Janssen, MD

More Information

Sponsor

William Janssen, MD

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Janssen, MD on 2026-02-06.