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Automated Analysis of EIT Data for PEEP Setting

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03653806
Enrollment
40
Registered
2018-08-31
Start date
2017-11-21
Completion date
2020-05-31
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxemic Respiratory Failure, Post-cardiac Surgery

Keywords

PEEP, Electrical Impedance Tomography

Brief summary

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.

Detailed description

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.

Interventions

OTHERcomputerized algorithm for automated analysis

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

Sponsors

University Hospital Schleswig-Holstein
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
develop automated EIT data algorithm for PEEP setting4 monthsThe 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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026