Acute Respiratory Distress Syndrome
Conditions
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.
Interventions
OTHEREsophageal 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| Oxygen Saturation | Up to Hour 2 (Day 1) | Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. |
Countries
United States
Outcome results
None listed