Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— ARDS  

Official title:

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715751
• Other study ID #: 2017P000596
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2021
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• ASV
Adaptive Support Ventilation
• Lung Protective Ventilation
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal Volume	Lung tidal volume in both ventilation modes (mL)	Day 1
Secondary	Driving Pressure (cmH20)	Driving pressure in both ventilation modes	Day 1
Secondary	Respiratory rate (BPM)	Respiratory Rate in both ventilation modes	Day 1
Secondary	Oxygenation (SpO2%)	Oxygenation (SpO2%) in both ventilation modes	Day 1
Secondary	CO2 clearance	CO2 clearance in both ventilation modes	Day 1
Secondary	Blood Gas pH	Blood Gas pH (units) in both ventilation modes	Day 1
Secondary	Blood Gas Partial Pressure of Oxygen	Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes	Day 1
Secondary	Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)	Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes	Day 1
Secondary	Composite measure (lung protectiveness) - Asynchrony index	Asynchrony index	Day 1
Secondary	Composite measure (lung protectiveness) - Number of Adjustments	Number of Adjustments	Day 1
Secondary	Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg	Time spent with tidal volumes less than or equal to 6cc/kg	Day 1
Secondary	Composite measure (lung protectiveness) - Driving pressures less than 15	Time spent at or under Driving pressures less than 15	Day 1
Secondary	Composite measure (lung protectiveness) - Plateau Pressure <30	Time spent at or under Plateau Pressure <30	Day 1
Secondary	Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%	Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%	Day 1
Secondary	Time to extubation	Time to liberation from mechanical ventilation (days)	30 Days
Secondary	ICU length of stay	Time to ICU discharge (days)	90 Days