Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

NCT05675696 | Withdrawn

• 1 other identifier: 22-00695
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Transpulmonary Driving Pressure

  Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.

  Up to Hour 2 (Day 1)

• Driving Pressure

  Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.

  Up to Hour 2 (Day 1)

• Work of Breathing (WOB)

  WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.

  Up to Hour 2 (Day 1)

• Pressure-Time Product (PTP)

  PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.

  Up to Hour 2 (Day 1)

Secondary Outcomes (5)

• Lung Compliance (C, l)

  Up to Hour 2 (Day 1)

• Chest Wall Compliance (C, cw)

  Up to Hour 2 (Day 1)

• Respiratory System Compliance (C, rs)

  Up to Hour 2 (Day 1)

• Oxygen Saturation

  Up to Hour 2 (Day 1)

• PaO2/FiO2 (P/F) Ratio

  Up to Hour 2 (Day 1)

Study Arms (1)

ARDS Patients Intubated on Mechanical Ventilation

EXPERIMENTAL

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.

Other: Esophageal Catheter

Interventions

Esophageal Catheter 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.

Also known as: PulmoTech Esophageal Pressure System (iEPS)

ARDS Patients Intubated on Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Beno Oppenheimer, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Beno.Oppenheimer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)