Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT03715751
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adaptive Support Ventilation
Other names: Adaptive Support Ventilation
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
Time frame: Day 1
Lung tidal volume in both ventilation modes (mL)
Time frame: Day 1
Driving pressure in both ventilation modes
Time frame: Day 1
Respiratory Rate in both ventilation modes
Time frame: Day 1
Oxygenation (SpO2%) in both ventilation modes
Time frame: Day 1
CO2 clearance in both ventilation modes
Time frame: Day 1
Blood Gas pH (units) in both ventilation modes
Time frame: Day 1
Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes
Time frame: Day 1
Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes
Time frame: Day 1
Asynchrony index
Time frame: Day 1
Number of Adjustments
Time frame: Day 1
Time spent with tidal volumes less than or equal to 6cc/kg
Time frame: Day 1
Time spent at or under Driving pressures less than 15
Time frame: Day 1
Time spent at or under Plateau Pressure <30
Time frame: Day 1
Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%
Time frame: 30 Days
Time to liberation from mechanical ventilation (days)
Time frame: 90 Days
Time to ICU discharge (days)
Beth Israel Deaconess Medical Center
Other
Acronym: ARDS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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