Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Transpulmonary Driving Pressure
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Transpulmonary Driving Pressure
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Lung Compliance (C, l)(Up to Hour 2 (Day 1))
- Respiratory System Compliance (C, rs)(Up to Hour 2 (Day 1))
- Chest Wall Compliance (C, cw)(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))