Clinical trial NCT06544148: Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study
Official title: Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study (PAP-EIT Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Artery Hypertension
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2024-08-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study the investigators plan to enroll 28 patients with complete datasets for evaluation of PAP derived by PAC and EIT for a minimum duration of 4 hours in the ICU at Inselspital (Bern) with clinical decision to monitor PAP using a PAC.

Brief 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).


Eligibility criteria: Inclusion criteria:

* Age ≥ 18-year-old.
* Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.

Exclusion criteria:

* Patients with implanted or external thoracic electronic devices (e.g., pacemaker) or thoracic metal implants.
* Known pregnancy or lactating patients.
* Open lung injuries or pneumothorax.
* Open wounds, drainages, burns or rashes of the upper thorax.
* Estimated thoracic perimeter smaller than 66 cm or larger than 134 cm.
* Known allergies to wound dressings or adhesives (e.g., gel electrodes)

Primary outcomes:
measure: Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Data acceptance rate
timeFrame: Up to 48 hours
measure: Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability)
timeFrame: Up to 48 hours
measure: Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements
timeFrame: Up to 48 hours
measure: Agreement between EIT-derived and ventilator-measured respiratory parameters
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Universitätsklinik für Intensivmedizin
Study officials:
affiliation: Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
name: Kaspar F Bachmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
name: Carmen A Pfortmueller, MD
role: STUDY_DIRECTOR
References: