NCT07184580

Brief Summary

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1). It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4). Despite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8). Recently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary "pulsatility," thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10). In this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies. Standard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed. This registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring. Data will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient. Data collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems. There are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings. Patients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay. As this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year. Inclusion Criteria for ICU Patients:

  • Patient aged more than 12 years old (no pediatric EIT belt)
  • Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Oct 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Oct 2025Apr 2031

First Submitted

Initial submission to the registry

August 26, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

August 26, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

ARDSRecruitment manoeuvresProne positioningPEEP optimizationEITElectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    Assessment of mortality

    up to 30 days

Secondary Outcomes (4)

  • PaO2/FiO2 ratio

    During the measurement using the EIT in the ICU

  • Hospital mortality rate

    Through hospital discharge (average of 14 days)

  • Ventilation free days

    28 days since the start of ventilation

  • Mechanical power

    During the measurement using the EIT in the ICU

Study Arms (2)

Mechanically ventilated patients

Mechanically ventilated patients for which an EIT belt has been placed, for PEEP optimization, ventilation monitoring, prone positioning evaluation,...

Non-invasive ventilation patients

Patients included in the study who are only on

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All critical care patients for whom clinicians estimated the need for EIT measurements could be included, except pediatric patients under 12 years of age, as the belt used for this device is not designed for children.

You may qualify if:

  • Patient aged more than 12 years old (no pediatric EIT belt)
  • Patient monitored by an EIT belt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.

    PMID: 30776290BACKGROUND
  • He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.

    PMID: 34193224BACKGROUND
  • Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.

    PMID: 38512400BACKGROUND
  • Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.

    PMID: 36650593BACKGROUND
  • Kim Y, Webster JG, Tompkins WJ. Electrical impedance imaging of the thorax. J Microw Power. 1983 Sep;18(3):245-57. doi: 10.1080/16070658.1983.11689329.

    PMID: 6558130BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, intensivist, principal investigator

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 22, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

September 22, 2025

Record last verified: 2025-09