PEEP and Spontaneous Breathing During ARDS

Fondazione Policlinico Universitario Agostino Gemelli IRCCS16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome

Interventions

Mechanical VentilationOTHER

Respiratory support through mechanical ventilator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Outcomes

Primary Outcomes

Inspiratory effort

The negative deflection in esophageal pressure during inspiration

Time frame: 45 minutes

Secondary Outcomes

Oxygenation

Ratio of PaO2 to FiO2

Time frame: 45 minutes

Respiratory mechanics

Respiratory mechanics assessed by end-inspiratory occlusion

Time frame: 45 minutes

Lung mechanics

Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion

Time frame: 45 minutes

Work of breathing

Esopghageal pressure pressure-time product per minute

Time frame: 45 minutes

Respiratory rate

Respiratory rate per minute

Time frame: 45 minutes

Regional Tidal volume distribution

Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography

Time frame: 45 minutes

Alveolar recruitment

Change in end-expiratory lung impedance, assessed by electrical impedance tomography

Time frame: 45 minutes

Pendelluft

Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration

Data from ClinicalTrials.gov

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