Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

NCT ID: NCT05675696

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-06-01

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ARDS Patients Intubated on Mechanical Ventilation

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.

Group Type: EXPERIMENTAL

Esophageal Catheter

Intervention Type: OTHER

Newly designed external monitor that will capture esophageal pressure from a proprietary nasogastric tube combined with simultaneous pressure, flow, and volume measurements from the ventilator tubing.

Interventions

Esophageal Catheter

Newly designed external monitor that will capture esophageal pressure from a proprietary nasogastric tube combined with simultaneous pressure, flow, and volume measurements from the ventilator tubing.

Intervention Type: OTHER

Other Intervention Names

PulmoTech Esophageal Pressure System (iEPS)

Eligibility Criteria

Inclusion Criteria

• 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
• Triggering breaths on the ventilator
• Treating medical team agrees with patient participation

Exclusion Criteria

• Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
• Shock that requires ≥ 2 vasopressors
• pH on arterial blood gas ≤7.25
• Minute ventilation ≥ 14L/min
• Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
• Severe ARDS with P/F ratio <60
• Pregnancy
• Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
• Decision to withhold life-sustaining treatment
• Patients who are not expected to survive for 24 hours
• Lack of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beno Oppenheimer, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

Tisch Hospital

New York, New York, United States

Countries

United States

Other Identifiers

22-00695

Identifier Type: -

Identifier Source: org_study_id