Clinical trial NCT03653806: Automated Analysis of EIT Data for PEEP Setting
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hypoxemic Respiratory Failure
Post-cardiac Surgery
Keywords: PEEP
Electrical Impedance Tomography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
name: Erasmus Medical Center
First posted: 2018-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post cardiac- surgery and patients with acute hypoxic respiratory failure

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.

Eligibility criteria: 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

Primary outcomes:
measure: develop automated EIT data algorithm for PEEP setting
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Serge Heines
Study officials:
affiliation: Maastricht University Medical Center
name: Dennis Bergmans
role: STUDY_CHAIR
References:
citation: Bodenstein M, David M, Markstaller K. Principles of electrical impedance tomography and its clinical application. Crit Care Med. 2009 Feb;37(2):713-24. doi: 10.1097/CCM.0b013e3181958d2f.
citation: Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
citation: Long Y, Liu DW, He HW, Zhao ZQ. Positive End-expiratory Pressure Titration after Alveolar Recruitment Directed by Electrical Impedance Tomography. Chin Med J (Engl). 2015 Jun 5;128(11):1421-7. doi: 10.4103/0366-6999.157626.