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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Artery Hypertension
• Intervention / Treatment: Device: Electrical impedance tomography

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

• Study Contact: Name: Kaspar F Bachmann, MD; Phone Number: +41 31 632 21 11; Email: kaspar.bachmann@faculty.unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital Bern, Universitätsklinik für Intensivmedizin
    • Contact: Carmen A Pfortmueller, MD; Phone Number: +41 31 632 21 11; Email: intensivmedizin@insel.ch
    • Principal Investigator: Kaspar F Bachmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All Study Participants

Device: Electrical impedance tomography; In addition to routine critical care with a pulmonary artery catheter already in place (PAC), an electrical impedance tomography (EIT) belt will be placed in patients enrolled in this study. Data will be analyzed offline and clinical trajectory and/or decisions will not be impacted by this additional monitoring. EIT is a non-invasive, safe, and radiation-free medical imaging modality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Investigators: Principal Investigator: Kaspar F Bachmann, MD, Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Study Director: Carmen A Pfortmueller, MD, Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2027

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension
• Other Study ID Numbers: 2024-00435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No