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

NCT ID: NCT06544148

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2027-08-05

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

All Study Participants

Electrical impedance tomography

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaspar F Bachmann, MD

Role: PRINCIPAL_INVESTIGATOR

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

Carmen A Pfortmueller, MD

Role: STUDY_DIRECTOR

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

Locations

Inselspital Bern, Universitätsklinik für Intensivmedizin

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Kaspar F Bachmann, MD

Role: CONTACT

kaspar.bachmann@faculty.unibe.ch

+41 31 632 21 11

Facility Contacts

Carmen A Pfortmueller, MD

Role: primary

intensivmedizin@insel.ch

+41 31 632 21 11

Other Identifiers

2024-00435

Identifier Type: -

Identifier Source: org_study_id