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

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

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

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Other: Adjustment of ventilator settings by EIT

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24103
      • University Medical Center Schleswig Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adjustment of ventilator settings by EIT; Individual Adjustment of Ventilator settings using an algorithm based on electrical impedance tomography.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Publications and helpful links

General Publications

• Becher T, Buchholz V, Hassel D, Meinel T, Schadler D, Frerichs I, Weiler N. Individualization of PEEP and tidal volume in ARDS patients with electrical impedance tomography: a pilot feasibility study. Ann Intensive Care. 2021 Jun 2;11(1):89. doi: 10.1186/s13613-021-00877-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): April 4, 2019
• Study Completion (ACTUAL): April 4, 2019

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UKSH-EIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED