Combining Electrical Impedance Tomography and Thoracic Ultrasound Toinvestigate Dynamic Changes

Combining Electrical Impedance Tomography and Thoracic Ultrasound to Investigate Dynamic Changes of Respiratory Effort, and Regional & End-expiratory Lung Volume in Mechanically Ventilated Patients.

1. To evaluate the dynamic changes of lung ultrasound during electrical impedance tomography (EIT) PEEP titration and across the first week of ARDS.
2. To asses respiratory effort by diaphragmatic function, esophageal pressure, and EIT (Pendelluft phenomenon), and hyperinflammatory biomarkers, to predict P-SILI.
3. To develop predictive models for weaning success based on integrated EELI and thoracic ultrasound.

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS (Moderate or Severe)
• Intervention / Treatment: Diagnostic test: Electrical impedance tomography

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Yao-Wen Kuo; Phone Number: 886+972651821; Email: kyw@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.

Description

Inclusion Criteria:

• Adult >18 y/o.
• Patient intubated and receiving mechanical ventilation > 24 hours.
• Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.

Exclusion Criteria:

• Presence of Implanted Electronic Devices (pacemakers, implantable cardioverter-defibrillators).
• Pregnancy.
• No consent/inability to obtain consent and appropriate legal representative not available.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARDS	Correlation of LUS aeration scores and overdistension metrics (e.g., A-line prominence, reduced lung sliding) with EIT parameters, including hyperdistension (%), collapse (%), and ΔEELI. Correlation of P-SILI risk with diaphragmatic function (ultrasound-measured excursion and thickening fraction), esophageal pressure variations (ΔPes, ΔPdi), pendelluft dynamics (phase shift, amplitude difference from EIT), and hyperinflammatory biomarkers (e.g., IL-6, IL-8).	From enrollment to the end of treatment at 1 weeks.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yao-Wen Kuo, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 19, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 27, 2025
• First Submitted That Met QC Criteria: April 27, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: electrical impedance tomography; Chest ultrasound
• Other Study ID Numbers: 202502091RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No