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Clinical Trials/NCT06544148
NCT06544148
Recruiting
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country28 target enrollmentAugust 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Artery Hypertension
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
28
Locations
1
Primary Endpoint
Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 5, 2024
End Date
August 5, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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