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Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASV
Lung Protective Ventilation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Respiratory Distress Syndrome focused on measuring Adaptive Support Ventilation, ARDS, Esophageal Pressure, Mechanical Ventilation, Transpulmonary Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ASV

Lung Protective Ventilation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tidal Volume
Lung tidal volume in both ventilation modes (mL)

Secondary Outcome Measures

Driving Pressure (cmH20)
Driving pressure in both ventilation modes
Respiratory rate (BPM)
Respiratory Rate in both ventilation modes
Oxygenation (SpO2%)
Oxygenation (SpO2%) in both ventilation modes
CO2 clearance
CO2 clearance in both ventilation modes
Blood Gas pH
Blood Gas pH (units) in both ventilation modes
Blood Gas Partial Pressure of Oxygen
Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)
Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes
Composite measure (lung protectiveness) - Asynchrony index
Asynchrony index
Composite measure (lung protectiveness) - Number of Adjustments
Number of Adjustments
Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg
Time spent with tidal volumes less than or equal to 6cc/kg
Composite measure (lung protectiveness) - Driving pressures less than 15
Time spent at or under Driving pressures less than 15
Composite measure (lung protectiveness) - Plateau Pressure <30
Time spent at or under Plateau Pressure <30
Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%
Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%
Time to extubation
Time to liberation from mechanical ventilation (days)
ICU length of stay
Time to ICU discharge (days)

Full Information

First Posted
August 15, 2018
Last Updated
March 7, 2022
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03715751
Brief Title
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
Acronym
ARDS
Official Title
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Adaptive Support Ventilation, ARDS, Esophageal Pressure, Mechanical Ventilation, Transpulmonary Pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASV
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lung Protective Ventilation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ASV
Other Intervention Name(s)
Adaptive Support Ventilation
Intervention Description
Adaptive Support Ventilation
Intervention Type
Other
Intervention Name(s)
Lung Protective Ventilation
Intervention Description
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
Primary Outcome Measure Information:
Title
Tidal Volume
Description
Lung tidal volume in both ventilation modes (mL)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Driving Pressure (cmH20)
Description
Driving pressure in both ventilation modes
Time Frame
Day 1
Title
Respiratory rate (BPM)
Description
Respiratory Rate in both ventilation modes
Time Frame
Day 1
Title
Oxygenation (SpO2%)
Description
Oxygenation (SpO2%) in both ventilation modes
Time Frame
Day 1
Title
CO2 clearance
Description
CO2 clearance in both ventilation modes
Time Frame
Day 1
Title
Blood Gas pH
Description
Blood Gas pH (units) in both ventilation modes
Time Frame
Day 1
Title
Blood Gas Partial Pressure of Oxygen
Description
Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes
Time Frame
Day 1
Title
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)
Description
Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Asynchrony index
Description
Asynchrony index
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Number of Adjustments
Description
Number of Adjustments
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg
Description
Time spent with tidal volumes less than or equal to 6cc/kg
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Driving pressures less than 15
Description
Time spent at or under Driving pressures less than 15
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Plateau Pressure <30
Description
Time spent at or under Plateau Pressure <30
Time Frame
Day 1
Title
Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%
Description
Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%
Time Frame
Day 1
Title
Time to extubation
Description
Time to liberation from mechanical ventilation (days)
Time Frame
30 Days
Title
ICU length of stay
Description
Time to ICU discharge (days)
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Talmor, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

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