ARDS: Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03715751

Collaborator

(none)

Enrollment

Location

Arms

35.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Other: ASV Other: Lung Protective Ventilation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

Actual Study Start Date :

Feb 14, 2018

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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 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 Adaptive Support Ventilation Other Names: Adaptive Support Ventilation
Active Comparator: Lung Protective Ventilation 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 Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.

Arm

Intervention/Treatment

Active Comparator: 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 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

Adaptive Support Ventilation

Other Names:

Adaptive Support Ventilation

Active Comparator: Lung Protective Ventilation

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

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

Outcome Measures

Primary Outcome Measures

Tidal Volume [Day 1]
Lung tidal volume in both ventilation modes (mL)

Secondary Outcome Measures

Driving Pressure (cmH20) [Day 1]
Driving pressure in both ventilation modes
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
Composite measure (lung protectiveness) - Number of Adjustments [Day 1]
Number of Adjustments
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.