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Completed

NCT Number: NCT03653806

Automated Analysis of EIT Data for PEEP Setting

First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the "optimal" positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse.

Second: to compare the results of the algorithm with the current standard of care clinical judgement of an experienced ventilation practitioner.

Completed

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Post-cardiac Surgery Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Serge Heines

Maastricht, 622HX, Netherlands

About this study

The study will be performed at the Intensive Care Unit, Maastricht University Medical Centre. The investigators routinely apply EIT (Pulmovista, Dräger, Lübeck. Germany) in mechanically ventilated patients to optimize the ventilator settings .

An algorithm will be developed by the Institute of Technical Medicine, Furtwangen University, Germany. The algorithm will automatically detect changes in both PEEP and inspiratory pressures. For each PEEP step and/or changes in inspiratory pressure the difference in regional alveolar overdistension and alveolar collapse will be calculated. This makes it possible to select the optimal ventilator setting depending on the best compromise between alveolar overdistension and alveolar collapse.

The algorithm will be tested in 40 EIT guided mechanically ventilated patients. EIT measurements will be performed during an incremental and decremental PEEP trial. The EIT measurement will be performed in the same way as during standard clinical care. EIT data will be analysed offline by a ventilation practitioner with experience in EIT and with the newly developed algorithm. The resulting advice on optimal ventilator settings will be compared for inter-observer variability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mechanically ventilated in a volume or pressure controlled mode
  • ventilator settings guided by EIT

Exclusion criteria

  • Participants who specifically opt-out regarding the use of the data for research purpose
  • Internal pacemaker, Implantable Cardioverter Defibrillator
  • Skin lesions, dressings at the thorax, hindering belt placement
  • Thoracic circumference < 70 cm
  • Thoracic circumference > 150 cm
  • BMI > 50

Treatment and study plan

computerized algorithm for automated analysis

Other

First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the "optimal" positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse.

Second: to compare the results of the algorithm with the current standard of care clinical judgement of experienced EIT users

Primary outcomes

  1. develop automated EIT data algorithm for PEEP setting

    Time frame: 4 months

    The automated algorithm will give an advise on PEEP and delta pressure settings, based upon the EIT data, which is in accordance with the decision of the investigator

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Erasmus Medical Center
  • University Hospital Schleswig-Holstein

Registry information

Official study title

Comparing the Results of a Computer Analysis Algorithm With Clinical Decisions in a Patient With Electrical Impedance Tomography Guided Ventilator Settings Regarding Optimal Positive End Expiratory Pressure and Inspiratory Pressure

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2018
Registry last updated
Nov 5, 2020

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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