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Clinical Trials/NCT06958770
NCT06958770
Not yet recruiting
Not Applicable

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

National Taiwan University Hospital0 sites50 target enrollmentStarted: May 19, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
ARDS

Overview

Brief Summary

  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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

ARDS

Time Frame: From enrollment to the end of treatment at 1 weeks.

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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