Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study
NCT Number: NCT06544148
Acronym: PAP-EIT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Artery Hypertension
Interventions: DEVICE: Electrical impedance tomography
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2027-08-05
Locations: Inselspital Bern, Universitätsklinik für Intensivmedizin, Bern, 3010, Switzerland

Summary:
To assess whether changes in electrical impedance - measured using an electrical impedance tomography (EIT) chest belt - can be used to derive changes in pulmonary artery pressure (PAP) in critically ill patients when compared to invasive gold-standard PAP measured using pulmonary artery catheter (PAC).

Primary Outcome Measures: Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure, The primary outcome is the difference - expressed as mean and standard deviation (SD) - between changes in EIT-derived pulmonary artery pressure (ΔPAP_EIT), derived from changes in the pulmonary pulse arrival time, and changes in pulmonary artery catheter-based pulmonary artery pressure (ΔPAP_PAC). This will be measured over recording periods of up to 48 hours., Up to 48 hours
Secondary Outcome Measures: Data acceptance rate, Data acceptance rate, i.e., the percentage of total recording duration during which lung EIT signals show pulmonary pressure morphology and thus allow to estimate EIT-derived PAP values., Up to 48 hours|Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability), The trending ability will be assessed using four quadrant plot analysis to calculate the concordance rate between EIT-derived and PAC-measured pulmonary artery pressure changes. The concordance rate is defined as the percentage of data points in which both methods agree on the direction of change (increase or decrease) in pulmonary artery pressure., Up to 48 hours|Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements, The difference between EIT-derived cardiac output (CO_EIT) and pulmonary artery catheter-based cardiac output (CO_PAC) will be calculated. This will be expressed as mean difference ± standard deviation in L/min. The ability of EIT to track changes in cardiac output over time will be evaluated by comparing directional changes in CO_EIT with corresponding changes in CO_PAC. This will be reported as the percentage of concordant directional changes between the two methods., Up to 48 hours|Agreement between EIT-derived and ventilator-measured respiratory parameters, This outcome assesses the ability of EIT to measure key respiratory parameters compared to the mechanical ventilator measurements. The difference between EIT-derived tidal volume and ventilator-measured tidal volume as well as the difference between EIT-derived respiratory rate and ventilator-measured respiratory rate will be calculated and expressed as mean difference ± standard deviation. Other ventilation-related parameters: Additional parameters such as end-expiratory lung volume changes or regional ventilation distribution may also be assessed, depending on the capabilities of the EIT system and the available ventilator data., Up to 48 hours