Acute Respiratory Distress Syndrome
Conditions
Keywords
Adaptive Support Ventilation, ARDS, Esophageal Pressure, Mechanical Ventilation, Transpulmonary Pressure
Brief summary
The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.
Detailed description
This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover. After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements. Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.
Interventions
OTHERASV
Adaptive Support Ventilation
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years of age 2. Receiving mechanical ventilation in an intensive care unit 3. ARDS, as defined by the Berlin definition: 1. Hypoxemic respiratory failure with PaO2 / FiO2 ratio \< 300 mmHg 2. Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days 3. Respiratory failure not fully explained by cardiac failure or fluid overload 4. Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O 4. Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.
Exclusion criteria
1. Clinical team refusal 2. Esophageal injury or contraindication precluding placement of the esophageal balloon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal Volume | Day 1 | Lung tidal volume in both ventilation modes (mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate (BPM) | Day 1 | Respiratory Rate in both ventilation modes |
| Oxygenation (SpO2%) | Day 1 | Oxygenation (SpO2%) in both ventilation modes |
| CO2 clearance | Day 1 | CO2 clearance in both ventilation modes |
| Blood Gas pH | Day 1 | Blood Gas pH (units) in both ventilation modes |
| Blood Gas Partial Pressure of Oxygen | Day 1 | Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes |
| Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) | Day 1 | Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes |
| Composite measure (lung protectiveness) - Asynchrony index | Day 1 | Asynchrony index |
| Driving Pressure (cmH20) | Day 1 | Driving pressure in both ventilation modes |
| Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg | Day 1 | Time spent with tidal volumes less than or equal to 6cc/kg |
| Composite measure (lung protectiveness) - Driving pressures less than 15 | Day 1 | Time spent at or under Driving pressures less than 15 |
| Composite measure (lung protectiveness) - Plateau Pressure <30 | Day 1 | Time spent at or under Plateau Pressure \<30 |
| Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88% | Day 1 | Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) \>88% |
| Time to extubation | 30 Days | Time to liberation from mechanical ventilation (days) |
| ICU length of stay | 90 Days | Time to ICU discharge (days) |
| Composite measure (lung protectiveness) - Number of Adjustments | Day 1 | Number of Adjustments |
Countries
United States
Outcome results
None listed