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Completed

NCT Number: NCT03715751

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age
  • Receiving mechanical ventilation in an intensive care unit
  • ARDS, as defined by the Berlin definition:
  • Hypoxemic respiratory failure with PaO2 / FiO2 ratio < 300 mmHg
  • Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
  • Respiratory failure not fully explained by cardiac failure or fluid overload
  • Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O
  • Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.

Exclusion criteria

  • Clinical team refusal
  • Esophageal injury or contraindication precluding placement of the esophageal balloon

Treatment and study plan

ASV

Other

Adaptive Support Ventilation

Other names: Adaptive Support Ventilation

Lung Protective Ventilation

Other

Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.

Primary outcomes

  1. Tidal Volume

    Time frame: Day 1

    Lung tidal volume in both ventilation modes (mL)

Secondary outcomes

  1. Driving Pressure (cmH20)

    Time frame: Day 1

    Driving pressure in both ventilation modes

  2. Respiratory rate (BPM)

    Time frame: Day 1

    Respiratory Rate in both ventilation modes

  3. Oxygenation (SpO2%)

    Time frame: Day 1

    Oxygenation (SpO2%) in both ventilation modes

  4. CO2 clearance

    Time frame: Day 1

    CO2 clearance in both ventilation modes

  5. Blood Gas pH

    Time frame: Day 1

    Blood Gas pH (units) in both ventilation modes

  6. Blood Gas Partial Pressure of Oxygen

    Time frame: Day 1

    Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes

  7. Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)

    Time frame: Day 1

    Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes

  8. Composite measure (lung protectiveness) - Asynchrony index

    Time frame: Day 1

    Asynchrony index

  9. Composite measure (lung protectiveness) - Number of Adjustments

    Time frame: Day 1

    Number of Adjustments

  10. Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg

    Time frame: Day 1

    Time spent with tidal volumes less than or equal to 6cc/kg

  11. Composite measure (lung protectiveness) - Driving pressures less than 15

    Time frame: Day 1

    Time spent at or under Driving pressures less than 15

  12. Composite measure (lung protectiveness) - Plateau Pressure <30

    Time frame: Day 1

    Time spent at or under Plateau Pressure <30

  13. Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%

    Time frame: Day 1

    Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%

  14. Time to extubation

    Time frame: 30 Days

    Time to liberation from mechanical ventilation (days)

  15. ICU length of stay

    Time frame: 90 Days

    Time to ICU discharge (days)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Acronym: ARDS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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