Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study

Recruiting

• Conditions: Pulmonary Artery Hypertension
• Interventions: Device: Electrical impedance tomography

• Registration Number: NCT06544148
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study Start: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-08-05
• Study Completion: 2027-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Study Participants	Electrical impedance tomography	-

Primary Outcome Measures

Name	Time	Method
Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure	Up to 48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Data acceptance rate	Up to 48 hours	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.
Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements	Up to 48 hours	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.
Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability)	Up to 48 hours	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.
Agreement between EIT-derived and ventilator-measured respiratory parameters	Up to 48 hours	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.

Trial Locations

Locations (1)

Inselspital Bern, Universitätsklinik für Intensivmedizin; 🇨🇭 Bern, Switzerland