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Pleural Line SlidingNCT06833151

Ultrasound Measurement of Pleural Line Sliding as a Surrogate Indicator of Lung Volume Change: A Comparative Study With Ventilator Volume Data

An observational study of Pleural Line Sliding, run by National Taiwan University Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The pleural line is a commonly observed structure in clinical ultrasound, used to evaluate pulmonary pathophysiology such as pulmonary edema, pneumothorax, or pneumonia. During the respiratory cycle, the pleural line undergoes displacement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pleural Line Sliding
What is being tested?
Ultrasound Respiratory Assessment
Type of treatment
Medical device
How many people
12 participants
Where
1 siteTaiwan
Study dates
6 Feb 2025to 31 Dec 2025
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: Patient with endotracheal tube and ventilator use

Who may be able to join

  • Patient with endotracheal tube and ventilator use

Who cannot join

  • Age under 18 y/o

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Pleural Line Sliding as a Surrogate Indicator of Lung Volume Change

The pleural line is a commonly observed structure in clinical ultrasound, used to evaluate pulmonary pathophysiology such as pulmonary edema, pneumothorax, or pneumonia. During the respiratory cycle, the pleural line undergoes displacement. In the inspiratory phase, the tidal volume increases, leading to an increase in displacement, while in the expiratory phase, the tidal volume decreases, resulting in reduced displacement. Therefore, we hypothesize that this displacement could serve as an indicator of tidal volume changes during respiration.

This study is a retrospective proof of concept study, reviewing cases from January to December 2012, involving 6 to 12 patients who were intubated and on mechanical ventilation with synchronized lung ultrasound recordings. The respiratory parameters and lung ultrasound recordings of the patients were anonymized after being downloaded for subsequent analysis.

Read more

For lung ultrasound analysis, we selected ultrasound recordings of the right lower lung apex at the costophrenic angle along the right mid-axillary line. Using the open-source image processing tool ImageJ 1.4, the pleural line corresponding to the right lower lung apex was enhanced and its terminal coordinates extracted. During respiration, the right lower lung apex moves with the breathing cycle, and the pleural line exhibits corresponding motion. The terminal coordinates of the pleural line also shift during respiration, and a plot of this displacement against time is generated to create the pleural line sliding displacement curve.

From the numerical data downloaded from the ventilator, we extracted the tidal volume curve against time during the patient's respiratory cycle. Based on the ventilator's time records, we selected the time segment that corresponded to the pleural line sliding displacement curve. The tidal volume curve and pleural line sliding displacement curve data for the same time period were extracted and synchronized using interpolation.

Linear regression was then performed on the synchronized numerical data of the two curves to obtain the correlation coefficient. Based on the correlation coefficient, the relationship between pleural line sliding displacement and tidal volume can be determined, which further indicates whether pleural line sliding displacement could serve as a surrogate indicator for tidal volume.

Being tested
Ultrasound Respiratory Assessment
Keywords
Pleural Line Sliding, Tidal Volume, Ultrasound Respiratory Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound Respiratory AssessmentDevice

    For lung ultrasound analysis, we selected ultrasound recordings of the right lower lung apex at the costophrenic angle along the right mid-axillary line. Using the open-source image processing tool ImageJ 1.4, the pleural line corresponding to the right lower lung apex was enhanced and its terminal coordinates extracted. During respiration, the right lower lung apex moves with the breathing cycle, and the pleural line exhibits corresponding motion. The terminal coordinates of the pleural line also shift during respiration, and a plot of this displacement against time is generated to create the pleural line sliding displacement curve.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pleural Line Sliding

    Pleural Line Sliding could serve as an indicator of tidal volume changes during respiration.

    Measured: Up to a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start6 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833151
Sponsor's protocol ID
202501005RINB
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only use in this study. Anonymisation.

Questions about this trial

What is this clinical trial studying?

An observational study of Pleural Line Sliding, run by National Taiwan University Hospital at 1 site in Taiwan.

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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pleural Line Sliding (time frame: Up to a year). 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 18 Feb 2025.

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