Pulmonary Artery HypertensionPAP-EITNCT06544148
Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study
An observational study of Pulmonary Artery Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Aug 2024to 5 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18-year-old.
- Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern, Universitätsklinik für Intensivmedizin
Bern, 3010
Carmen A Pfortmueller, MD, +41 31 632 21 11, intensivmedizin@insel.ch
Kaspar F Bachmann, MD
About this study
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)
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
- Being tested
- Electrical impedance tomography
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Not described Receives: Device: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours
Secondary outcomes (4)
Data acceptance rate
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.
Measured: Up to 48 hours
Concordance rate (%) of directional changes in pulmonary artery pressure between EIT and PAC measurements (Trending ability)
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.
Measured: Up to 48 hours
Accuracy and trending ability of EIT-derived cardiac output compared to PAC measurements
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.
Measured: Up to 48 hours
Agreement between EIT-derived and ventilator-measured respiratory parameters
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.
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 Aug 2024
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Responsible party
- Sponsor
- Investigators
- Kaspar F Bachmann, MD, Principal investigator, Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, SwitzerlandCarmen A Pfortmueller, MD, Study director, Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544148
- Sponsor's protocol ID
- 2024-00435
- Acronym
- PAP-EIT
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06544148
- Acronym / sponsor ID
- PAP-EIT / 2024-00435
- Conditions
- Pulmonary Artery Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Device: Electrical impedance tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18-year-old.
- Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomographyIn 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. | Device | All Study Participants |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaspar F Bachmann, MD principal investigator
Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Carmen A Pfortmueller, MD study director
Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaspar F Bachmann, MD (+41 31 632 21 11, kaspar.bachmann@faculty.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference between EIT-derived and PAC-measured changes in pulmonary artery pressure (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.