Automated Analysis of EIT Data for PEEP Setting

Completed

• Conditions: Acute Hypoxemic Respiratory Failure; Post-cardiac Surgery

• Registration Number: NCT03653806
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
develop automated EIT data algorithm for PEEP setting	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

Trial Locations

Locations (1)

Serge Heines; 🇳🇱 Maastricht, Netherlands