Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

NCT03715751 | Completed

• 1 other identifier: 2017P000596
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Adaptive Support Ventilation; ARDS; Esophageal Pressure; Mechanical Ventilation; Transpulmonary Pressure

Outcome Measures

Primary Outcomes (1)

• Tidal Volume

  Lung tidal volume in both ventilation modes (mL)

  Day 1

Secondary Outcomes (15)

• Driving Pressure (cmH20)

  Day 1

• Respiratory rate (BPM)

  Day 1

• Oxygenation (SpO2%)

  Day 1

• CO2 clearance

  Day 1

• Blood Gas pH

  Day 1

Study Arms (2)

ASV

ACTIVE COMPARATOR

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

Lung Protective Ventilation

ACTIVE COMPARATOR

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

Interventions

ASV OTHER

Adaptive Support Ventilation

Also known as: Adaptive Support Ventilation

ASV

Lung Protective Ventilation OTHER

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

Lung Protective Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Daniel Talmor, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edward Lowenstein Professor of Anesthesia

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: October 23, 2018
• Study Start: February 14, 2018
• Primary Completion: November 2, 2020
• Study Completion: January 31, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

US (1)