Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Other: Esophageal Catheter
- Registration Number
- NCT05675696
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARDS Patients Intubated on Mechanical Ventilation Esophageal Catheter 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.
- Primary Outcome Measures
Name Time Method Transpulmonary Driving Pressure Up to Hour 2 (Day 1) 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.
Driving Pressure Up to Hour 2 (Day 1) 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.
Work of Breathing (WOB) Up to Hour 2 (Day 1) 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.
Pressure-Time Product (PTP) Up to Hour 2 (Day 1) 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.
- Secondary Outcome Measures
Name Time Method Lung Compliance (C, l) Up to Hour 2 (Day 1) 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).Respiratory System Compliance (C, rs) Up to Hour 2 (Day 1) 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).Chest Wall Compliance (C, cw) Up to Hour 2 (Day 1) 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).Oxygen Saturation Up to Hour 2 (Day 1) Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
PaO2/FiO2 (P/F) Ratio Up to Hour 2 (Day 1) The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).
Trial Locations
- Locations (1)
Tisch Hospital
🇺🇸New York, New York, United States