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NCT Number: NCT06544148

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

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Key information

Conditions

Pulmonary Artery Hypertension Familial Primary Pulmonary Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital Bern, Universitätsklinik für Intensivmedizin

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Carmen A Pfortmueller, MD

CONTACT

[email protected]

+41 31 632 21 11

Kaspar F Bachmann, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

electrical impedance tomography

Device

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.

Primary outcomes

  1. Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure

    Time frame: 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 outcomes

  1. Data acceptance rate

    Time frame: 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.

  2. Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability)

    Time frame: 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.

  3. Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements

    Time frame: 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.

  4. Agreement between EIT-derived and ventilator-measured respiratory parameters

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaspar F Bachmann, MD

CONTACT

[email protected]

+41 31 632 21 11

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Registry information

Official study 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)

Acronym: PAP-EIT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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