Clinical Application of Electrical Impedance Tomography for Individual Adjustment of Ventilator Settings

University Hospital Schleswig-Holstein20 enrolled

Overview

First clinical application of an algorithm for individual adjustment of ventilator settings using electrical impedance tomography.

In patients suffering from early Acute Respiratory Distress Syndrome (ARDS), an algorithm for individual adjustment of positive end-expiratory pressure and tidal volume will be applied. After optimization of ventilator settings according to the ARDS Network protocol, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded. Subsequently, ventilator settings will be adjusted using an algorithm aiming at recruitment and avoiding tidal recruitment and overdistension using electrical impedance tomography (EIT). After 4 hours of EIT-based optimization ventilator settings, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded again. The results will be compared to the ARDS Network approach.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ARDS

Interventions

Adjustment of ventilator settings by EITOTHER

Diagnostic maneuvers (change in tidal volume, recruitment maneuvers) will be performed to detect overdistention, tidal recruitment and recruitability. Tidal volume will be reduced if overdistention is detected by EIT. Positive end-expiratory pressure will be increased if tidal recruitment or recruitability are detected.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute Respiratory Distress Syndrome (according to Berlin Definition) Exclusion Criteria: * Hemodynamic Instability (defined as mean arterial pressure \< 65 mmHg OR heart rate \< 40 / min OR heart rate \> 150 / min OR cardiac index \< 2.0 l/min/m\^2 DESPITE adequate fluid resuscitation and adequate therapy with inotropes and / or vasopressors) * Thoracic burns or severe skin injuries * High frequency oscillatory ventilation * Pregnancy * Severe chronic obstructive pulmonary disease (GOLD IV) * Esophageal varices \> grade I * Esophageal resection * Invasive ventilation prior to study inclusion for more than 72 hours after onset of ARDS * Inspiratory oxygen requirement \> 80%

Locations (1)

University Medical Center Schleswig Holstein

Kiel, Schleswig-Holstein, Germany

Outcomes

Primary Outcomes

Stress

Percentage of patients with lung stress (defined as trans-pulmonary pressure during an end-inspiratory hold) below 27 mbar after 4 hours of adjustment of ventilator settings with the algorithm.

Time frame: 4 hours

Strain

Percentage of patients with lung strain (defined as end-inspiratory lung volume divided by functional residual capacity) below 2.0 after 4 hours of adjustment of ventilator settings with the algorithm.

Time frame: 4 hours

Secondary Outcomes

Compliance

Respiratory system compliance (defined as expiratory tidal volume divided by driving pressure) will be measured after 4 hours of adjustment of ventilator settings with the algorithm

Time frame: 4 hours

Driving Pressure

Driving Pressure (defined as difference between airway plateau pressure and positive end-expiratory pressure) will be measured after 4 hours of adjustment of ventilator settings with the algorithm

Time frame: 4 hours

Standard Deviation of regional ventilation delay

Standard Deviation of regional ventilation delay, (as described in the publication of Muders et al, Crit Care Med Vol. 40, pp 903-911, 2012) will be measured after 4 hours of adjustment of ventilator settings with the algorithm

Time frame: 4 hours

PaO2 / FiO2 Ratio

The ratio between arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) will be measured after 4 hours of adjustment of ventilator settings with the algorithm

Time frame: 4 hours

Data from ClinicalTrials.gov

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