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Completed

NCT Number: NCT02703012

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

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

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Key information

Conditions

ARDS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Schleswig Holstein

Kiel, Schleswig-Holstein, 24103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Adjustment of ventilator settings by EIT

Other

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.

Primary outcomes

  1. Stress

    Time frame: 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.

  2. Strain

    Time frame: 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 outcomes

  1. Compliance

    Time frame: 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

  2. Driving Pressure

    Time frame: 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

  3. Standard Deviation of regional ventilation delay

    Time frame: 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

  4. PaO2 / FiO2 Ratio

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2016
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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