ARDS (Moderate or Severe)NCT06958770
Combining Electrical Impedance Tomography and Thoracic Ultrasound Toinvestigate Dynamic Changes
An observational study of ARDS (Moderate or Severe), run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Moderate or Severe)
- What is being tested?
- Electrical impedance tomography
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2025to 31 Dec 2028
- 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: Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.
Who may be able to join
- 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.
Who cannot join
- Presence of Implanted Electronic Devices (pacemakers, implantable cardioverter-defibrillators).
- Pregnancy.
- No consent/inability to obtain consent and appropriate legal representative not available.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combining Electrical Impedance Tomography and Thoracic Ultrasound to Investigate Dynamic Changes of Respiratory Effort, and Regional & End-expiratory Lung Volume in Mechanically Ventilated Patients.
- To evaluate the dynamic changes of lung ultrasound during electrical impedance tomography (EIT) PEEP titration and across the first week of ARDS.
- To asses respiratory effort by diaphragmatic function, esophageal pressure, and EIT (Pendelluft phenomenon), and hyperinflammatory biomarkers, to predict P-SILI.
- To develop predictive models for weaning success based on integrated EELI and thoracic ultrasound.
- Conditions
- ARDS (Moderate or Severe)
- Being tested
- Electrical impedance tomography
- Keywords
- Chest ultrasound, electrical impedance tomography
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDiagnostic test
Also called Lung ultrasound, Esophageal pressure, Oxygen consumption
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 1 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start19 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958770
- Sponsor's protocol ID
- 202502091RIND
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Electrical Impedance Tomography and Thoracic Ultrasound to Investigate Dynamic Changes of Respiratory Effort, and Regional & End-expiratory Lung Volume in Mechanically Ventilated Patients.
- ClinicalTrials.gov ID
- NCT06958770
- Acronym / sponsor ID
- 202502091RIND
- Conditions
- ARDS (Moderate or Severe)
- Keywords
- Chest ultrasound, electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2025 (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 evaluate the dynamic changes of lung ultrasound during electrical impedance tomography (EIT) PEEP titration and across the first week of ARDS.
- To asses respiratory effort by diaphragmatic function, esophageal pressure, and EIT (Pendelluft phenomenon), and hyperinflammatory biomarkers, to predict P-SILI.
- To develop predictive models for weaning success based on integrated EELI and thoracic ultrasound.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of Implanted Electronic Devices (pacemakers, implantable cardioverter-defibrillators).
- Pregnancy.
- No consent/inability to obtain consent and appropriate legal representative not available.
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 tomographyAlso: Lung ultrasound, Esophageal pressure, Oxygen consumption* 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. | Diagnostic test | – |
Primary outcome
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).
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 6 May 2025.
- 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.
Yao-Wen Kuo principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Moderate or Severe), run by National Taiwan University Hospital.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yao-Wen Kuo (886+972651821, kyw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARDS (time frame: From enrollment to the end of treatment at 1 weeks.). 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 6 May 2025.