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

Not Applicable

Completed

• Conditions: ARDS

• Registration Number: NCT02703012
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Status Verified: 2019-04
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stress	4 hours	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.
Strain	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
Compliance	4 hours	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
Standard Deviation of regional ventilation delay	4 hours	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
Driving Pressure	4 hours	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
PaO2 / FiO2 Ratio	4 hours	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

Trial Locations

Locations (1)

University Medical Center Schleswig Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany