Esophageal Catheter Assessment for Acute Respiratory Distress Syndrome

Overseen By Beno Oppenheimer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Esophageal abnormalities, Shock, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.

Who Is on the Research Team?

Beno Oppenheimer, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for adults on ventilators diagnosed with ARDS who are expected to need ventilation for at least 48 hours, can trigger breaths on the ventilator, and meet specific criteria for lung injury severity. It's not suitable for pregnant individuals, those with certain lung or esophageal conditions, severe shock patients, or if life-sustaining treatment is being withheld.

Inclusion Criteria

I am on a ventilator due to severe lung issues and expected to be on it for at least 48 hours.

Breathing too fast or too deeply while on the ventilator.

I have been diagnosed with ARDS, with or without chronic lung disease.

Exclusion Criteria

Lack of informed consent

You need to breathe in at least 14 liters of air per minute.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a one-to-two-hour study session using esophageal manometry to measure lung stress during mechanical ventilation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study session

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Esophageal Catheter

Trial Overview The study tests how well an esophageal catheter can measure hidden lung stress in patients receiving lung protective mechanical ventilation. This could help identify and reduce additional lung damage during treatment.

How Is the Trial Designed?

Group I: ARDS Patients Intubated on Mechanical Ventilation Experimental Treatment 1 Intervention

ARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+