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

ARDS Clinical Trial

— CLEAR  

Official title:

Pilot Clinical Study on Patient-Specific Adjustment of Ventilator Settings Using Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703012
• Other study ID #: UKSH-EIT-01
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 4, 2019

Study information

• Verified date: April 2019
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• ARDS
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• Adjustment of ventilator settings by EIT
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.

Locations

Country	Name	City	State
Germany	University Medical Center Schleswig Holstein	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours
Primary	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.	4 hours
Secondary	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	4 hours
Secondary	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	4 hours
Secondary	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	4 hours
Secondary	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	4 hours