An interventional study of Esophageal Catheter in Acute Respiratory Distress Syndrome, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
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Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
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.
Also known as: PulmoTech Esophageal Pressure System (iEPS)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Hour 2 (Day 1)
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).
Time frame: 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).
Time frame: 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).
Time frame: Up to Hour 2 (Day 1)
Oxygen Saturation
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Time frame: 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).
Time frame: Up to Hour 2 (Day 1)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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