Clinical Application of Electrical Impedance Tomography for Individual Adjustment of Ventilator Settings (CLEAR)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: ARDS

Treatments: Other: Adjustment of ventilator settings by EIT

Study type: Interventional

Funder types: Other

Identifiers

NCT02703012

UKSH-EIT-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Adjustment of ventilator settings by EIT

Experimental group

Description:

Individual Adjustment of Ventilator settings using an algorithm based on electrical impedance tomography.

Treatment:

Other: Adjustment of ventilator settings by EIT