An interventional study of ASV and Lung Protective Ventilation in Acute Respiratory Distress Syndrome, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Basic science
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
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ARDS, as defined by the Berlin definition:
Exclusion Criteria:
Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2\>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted to target the same minute ventilation achieved prior to any change in Vt. Patients will then be switched to ASV mode. The percentage minute volume (%minVol) will be adjusted to target the same minute ventilation as was achieved before the change. Settings will be maintained for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn.
Other: ASV
Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2\>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted (while leaving the Vt at 6cc/kg) to achieve the same minute ventilation. Patients will then be maintained on their current lung protective ventilation settings for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn.
Other: Lung Protective Ventilation
Adaptive Support Ventilation
Also known as: Adaptive Support Ventilation
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
Tidal Volume
Lung tidal volume in both ventilation modes (mL)
Time frame: Day 1
Driving Pressure (cmH20)
Driving pressure in both ventilation modes
Time frame: Day 1
Respiratory rate (BPM)
Respiratory Rate in both ventilation modes
Time frame: Day 1
Oxygenation (SpO2%)
Oxygenation (SpO2%) in both ventilation modes
Time frame: Day 1
CO2 clearance
CO2 clearance in both ventilation modes
Time frame: Day 1
Blood Gas pH
Blood Gas pH (units) in both ventilation modes
Time frame: Day 1
Blood Gas Partial Pressure of Oxygen
Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes
Time frame: Day 1
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)
Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes
Time frame: Day 1
Composite measure (lung protectiveness) - Asynchrony index
Asynchrony index
Time frame: Day 1
Composite measure (lung protectiveness) - Number of Adjustments
Number of Adjustments
Time frame: Day 1
Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg
Time spent with tidal volumes less than or equal to 6cc/kg
Time frame: Day 1
Composite measure (lung protectiveness) - Driving pressures less than 15
Time spent at or under Driving pressures less than 15
Time frame: Day 1
Composite measure (lung protectiveness) - Plateau Pressure <30
Time spent at or under Plateau Pressure \<30
Time frame: Day 1
Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%
Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) \>88%
Time frame: Day 1
Time to extubation
Time to liberation from mechanical ventilation (days)
Time frame: 30 Days
ICU length of stay
Time to ICU discharge (days)
Time frame: 90 Days
Plan to share: Undecided
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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