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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to hour 2 (day 1)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Driving Pressure

Pressure-Time Product (PTP)

Transpulmonary Driving Pressure

+1 more

Secondary outcome measures

Chest Wall Compliance (C, cw)

Lung Compliance (C, l)

Oxygen Saturation

+2 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,701 Total Patients Enrolled

Beno Oppenheimer, MDPrincipal InvestigatorNYU Langone Medical Center

Media Library

Esophageal Catheter Clinical Trial Eligibility Overview. Trial Name: NCT05675696 — N/A

Acute Respiratory Distress Syndrome Research Study Groups: ARDS Patients Intubated on Mechanical Ventilation

Acute Respiratory Distress Syndrome Clinical Trial 2023: Esophageal Catheter Highlights & Side Effects. Trial Name: NCT05675696 — N/A

Esophageal Catheter 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675696 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity for enrolment in this research experiment?

"Clinicaltrials.gov records show that this trial, which was initially publicized on January 1st 2023 and most recently updated on December 29th 2022 is not presently recruiting patients. However, there are 189 other active clinical trials seeking participants right now."

Answered by AI

What targets are researchers hoping to achieve through this investigation?

"Through a two-hour observation period, this trial will evaluate the effect of Driving Pressure on patient outcomes. Secondary metrics include Chest Wall Compliance (C, cw), Respiratory System Compliance (C, rs), and Oxygen Saturation. These measurements are calculated by taking Tidal Volume divided by differences between Esophageal/Airway pressures at PEEP or Fraction of oxygen-saturated hemoglobin relative to Total Hemoglobin in the blood respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

2024. "Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05675696.

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