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?

This trial explores how an esophageal catheter (a thin tube inserted into the esophagus) can help manage lung stress in patients with Acute Respiratory Distress Syndrome (ARDS) on mechanical ventilation. The researchers aim to determine if measuring pressure inside the esophagus with this catheter can help adjust ventilator settings to reduce lung stress. Individuals diagnosed with ARDS, who are intubated, and expected to need ventilation for at least 48 hours might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance ventilator care for ARDS patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this esophageal catheter is safe for ARDS patients?

Research has shown that using a tube in the esophagus to monitor chest pressures during breathing support is generally safe. Studies have found that complications from placing the tube are rare. Specifically, about 8.7% of people experienced nosebleeds, and 2.2% had a pneumothorax, where air leaks into the space between the lung and chest wall. These figures indicate that while some risks exist, they are uncommon. Overall, most patients tolerate the esophageal tube well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the esophageal catheter technique for Acute Respiratory Distress Syndrome (ARDS) because it offers a new way to measure and manage lung stress in patients on mechanical ventilation. Unlike traditional methods, which primarily rely on external assessments and settings, this technique uses an esophageal catheter to directly estimate pleural pressure, providing more accurate data on the patient's respiratory mechanics. This could potentially lead to more precise ventilator adjustments, reducing lung injury and improving outcomes for ARDS patients. Additionally, the catheter can double as a feeding tube, adding practicality and convenience in patient care.

What evidence suggests that the esophageal catheter is effective for assessing ARDS?

Research has shown that an esophageal catheter, which participants in this trial will receive, can help manage acute respiratory distress syndrome (ARDS) by improving air delivery to the lungs. Studies have found that this tool adjusts lung air pressure, crucial for preventing further lung damage. Specifically, monitoring with an esophageal balloon has effectively set the right air pressure, improved breathing, and reduced lung injury. Complications from using the catheter are rare, with only a small chance of minor issues like nosebleeds. This suggests that the esophageal catheter is a promising tool for better managing ARDS in patients requiring breathing machines. ^{2 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8759303/

Effect of Esophageal Pressure–guided Positive End ... Titration of positive end-expiratory pressure (PEEP) in acute respiratory distress syndrome (ARDS) ideally should balance potential benefits of lung recruitment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9442532/

Dynamic evaluation of the pulmonary protective effects of ... Patients with moderate to severe acute respiratory distress syndrome (ARDS) have been recommended to receive prone position ventilation (PPV).

3. jeccm.amegroups.org jeccm.amegroups.org/article/view/9012/html

Evaluating the safety of setting positive end-expiratory ... Complications related to esophageal pressure catheter placement were minimal, with 8.7% nosebleeds and 2.2% pneumothorax.

4. nature.com nature.com/articles/s41598-024-59790-1

Comparative analysis of novel esophageal pressure ... Transpulmonary pressure can be estimated using esophageal balloon (EB) catheters, which come in a variety of manufacturing configurations.

5. tpmap.org tpmap.org/submission/index.php/tpm/article/view/2138

EFFECTIVENESS OF ESOPHAGEAL BALLOON ... Conclusion: Esophageal balloon monitoring effectively optimizes PEEP in ARDS, enhancing respiratory mechanics and reducing lung injury.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490343/

Association of Breathing Effort With Survival in Patients ... Despite advancements in IMV management, mortality for ARDS patients requiring IMV remains high, ranging from 30% to 50% (1, 4–8). At the initial ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa0708638

Mechanical Ventilation Guided by Esophageal Pressure in ... Survival of patients with acute lung injury or the acute respiratory distress syndrome (ARDS) has been improved by ventilation with small ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2492877

Epidemiology, Patterns of Care, and Mortality for Patients ... Hospital mortality was 34.9% (95% CI, 31.4%-38.5%) for those with mild, 40.3% (95% CI, 37.4%-43.3%) for those with moderate, and 46.1% (95% CI, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9867326/

Practical Aspects of Esophageal Pressure Monitoring in ... The aim of this narrative review is to summarize the concept of esophageal pressure monitoring to assess transpulmonary pressures in patients ...