- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06833151
Ultrasound Measurement of Pleural Line Sliding as a Surrogate Indicator of Lung Volume Change: A Comparative Study With Ventilator Volume Data
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with endotracheal tube and ventilator use
Exclusion Criteria:
- Age under 18 y/o
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pleural Line Sliding
Time Frame: Up to a year
|
Pleural Line Sliding could serve as an indicator of tidal volume changes during respiration.
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Up to a year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202501005RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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