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

NCT06544148 | Recruiting

• 1 other identifier: 2024-00435
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Artery Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Data acceptance rate

  Up to 48 hours

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

  Up to 48 hours

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

  Up to 48 hours

• Agreement between EIT-derived and ventilator-measured respiratory parameters

  Up to 48 hours

Study Arms (1)

All Study Participants

Device: Electrical impedance tomography

Interventions

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.

All Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18-year-old.
• Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement: collaborator

Study Sites (1)

Inselspital Bern, Universitätsklinik für Intensivmedizin

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kaspar F Bachmann, MD

  Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Carmen A Pfortmueller, MD

  Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

  STUDY DIRECTOR

Central Study Contacts

Kaspar F Bachmann, MD

CONTACT

+41 31 632 21 11; kaspar.bachmann@faculty.unibe.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 9, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)