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Esophageal Catheter Assessment for Acute Respiratory Distress Syndrome

N/A

Waitlist Available

Led By Beno Oppenheimer, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours

Meets Berlin criteria for ARDS, with or without underlying chronic lung disease

Must not have

Decision to withhold life-sustaining treatment

Currently receiving extracorporeal membrane oxygenation (ECMO) therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to hour 2 (day 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial will measure how much effort patients put into breathing during lung protective ventilation, to help treat and prevent lung stress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the esophageal catheter placement and possible risks associated with measuring pressure inside the esophagus which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chosen not to receive life-sustaining treatments.

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I am currently on ECMO therapy.

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I have or might have air leaks in my lung area.

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I need two or more medications to maintain my blood pressure due to shock.

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My lung condition is severe, with a very low oxygen level.

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I have issues with my esophagus, face structure, or have had upper GI bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to hour 2 (day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to hour 2 (day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to hour 2 (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Driving Pressure

Pressure-Time Product (PTP)

Transpulmonary Driving Pressure

+1 more

Secondary study objectives

Chest Wall Compliance (C, cw)

Lung Compliance (C, l)

Oxygen Saturation

+2 more

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: ARDS Patients Intubated on Mechanical VentilationExperimental Treatment1 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.

0 / 8Eligibility criteria met