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Recruiting NCT06544148

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

— Observational Pulmonary Artery Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical impedance tomography.
Who it may be relevant to
Registry conditions: Pulmonary Artery Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure [Time frame: Up to 48 hours]
Secondary outcome measures (4)
  • Data acceptance rate [Time frame: Up to 48 hours]
  • Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability) [Time frame: Up to 48 hours]
  • Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements [Time frame: Up to 48 hours]
  • Agreement between EIT-derived and ventilator-measured respiratory parameters [Time frame: Up to 48 hours]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • Inselspital Bern, Universitätsklinik für Intensivmedizin — Bern

Identifiers

NCT: NCT06544148 · 2024-00435

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗