PEEP and Spontaneous Breathing During ARDS (EARDS)

Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS

Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Mechanical Ventilation

Detailed Description

This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition.

Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.

Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW [kg] = 45.5 + 0.91 [cm of height - 152.4]; male PBW [kg] = 50 + 0.91 [cm of height - 152.4]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt <8 ml/Kg PBW is not achieved.

In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Fondazione Policlinico Universitaro A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
• (b) assisted ventilation, as prescribed by the attending physician
• (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion

Exclusion Criteria:

Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low PEEP and full inspiratory synchronization; PEEP = 5 cmH2O + clinically selected pressure support (PSVclin)	Other: Mechanical Ventilation; Respiratory support through mechanical ventilator
EXPERIMENTAL: High PEEP and full inspiratory synchronization; PEEP = 15 cmH2O + clinically selected pressure support (PSVclin)	Other: Mechanical Ventilation; Respiratory support through mechanical ventilator
EXPERIMENTAL: Low PEEP and inspiratory desynchronization; PEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)	Other: Mechanical Ventilation; Respiratory support through mechanical ventilator
EXPERIMENTAL: High PEEP and inspiratory desynchronization; PEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)	Other: Mechanical Ventilation; Respiratory support through mechanical ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory effort	The negative deflection in esophageal pressure during inspiration	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	Ratio of PaO2 to FiO2	45 minutes
Respiratory mechanics	Respiratory mechanics assessed by end-inspiratory occlusion	45 minutes
Lung mechanics	Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion	45 minutes
Work of breathing	Esopghageal pressure pressure-time product per minute	45 minutes
Respiratory rate	Respiratory rate per minute	45 minutes
Regional Tidal volume distribution	Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography	45 minutes
Alveolar recruitment	Change in end-expiratory lung impedance, assessed by electrical impedance tomography	45 minutes
Pendelluft	Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration	45 minutes
Carbon dioxide	Blood carbon dioxide, as assessed by arterial blood gas analysis	45 minutes
Tidal volume	Average Tidal volume received by the patient	45 minutes
Dynamic transpulmonary driving pressure	The average positive swing in transpulmonary driving pressure during tidal breathing	45 minutes

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giuseppe Bello, MD, Fondazione Policlinico A. Gemelli IRCCS; Study Director: Massimo Antonelli, MD, Fondazione Policlinico A. Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): June 15, 2022
• Study Completion (ACTUAL): June 15, 2022

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: EARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual patient data will be made available upon a reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No