Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Esophageal Catheter

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beno Oppenheimer; Phone Number: 917-797-2128; Email: Beno.Oppenheimer@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Tisch Hospital
      • Contact: Beno Oppenheimer; Phone Number: 917-797-2128; Email: Beno.Oppenheimer@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.; Other Names: PulmoTech Esophageal Pressure System (iEPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Compliance (C, l)	Lung compliance is calculated as the tidal volume divided by the difference of transpulmonary pressure at end inspiration minus transpulmonary pressure at PEEP: (C, l) = tidal volume/(transpulmonary pressure at end inspiration - transpulmonary pressure at PEEP). Expressed in (ml/cmH2O).	Up to Hour 2 (Day 1)
Chest Wall Compliance (C, cw)	Chest wall compliance is calculated as the tidal volume divided by the difference of esophageal pressure at end inspiration minus esophageal pressure at PEEP: (C, cw) = tidal volume/(esophageal pressure at end inspiration - esophageal pressure at PEEP). Expressed in (ml/cmH2O).	Up to Hour 2 (Day 1)
Respiratory System Compliance (C, rs)	Respiratory System Compliance is calculated as the tidal volume divided by the difference of the airway pressure at end inspiration minus airway pressure at PEEP: (C, rs) = tidal volume/(airway pressure at end inspiration - airway pressure at PEEP). Expressed in (ml/cmH2O).	Up to Hour 2 (Day 1)
Oxygen Saturation	Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.	Up to Hour 2 (Day 1)
PaO2/FiO2 (P/F) Ratio	The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).	Up to Hour 2 (Day 1)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Beno Oppenheimer, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: December 29, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 22-00695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Beno Oppenheimer [Beno.Oppenheimer@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No