NCT06958770

Brief Summary

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

Trial Health

65
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started May 2025

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress27%
May 2025Dec 2028

First Submitted

Initial submission to the registry

April 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

April 27, 2025

Last Update Submit

April 27, 2025

Conditions

Keywords

Chest ultrasoundelectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

* Electrical impedance tomography (EIT):Assessing pulmonary function in chronic lung diseases. * Lung ultrasound:Assessing diaphragm atrophy in mechanically ventilated patients. * Esophageal pressure:The work of breathing, or the energy required by respiratory muscles to meet ventilatory demands, can be directly evaluated by esophageal pressure * Oxygen consumption:Indirectly evaluated by measuring oxygen consumption (V̇O2) during mechanical ventilation The oxygen cost of breathing, reflected the increase in V̇O2 when transitioning from mechanical ventilation to spontaneous breathing, has been shown to predict weaning outcomes.

Also known as: Lung ultrasound, Esophageal pressure, Oxygen consumption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Oxygen Consumption

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

  • Yao-Wen Kuo

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao-Wen Kuo

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2025

First Posted

May 6, 2025

Study Start

May 19, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share