Pleural Effusion DisorderNCT02809872
Ultrasound Estimation of Pleural Effusion in the Sitting Patients
An observational study of Pleural Effusion Disorder and Thoracic Ultrasound, run by Scarlata, Simone, M.D. at 1 site in Italy.
Trial summary
The aim of this study is the feasibility assessment of a simple and affordable model for the quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the effusion in correspondence of the midline of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Disorder, Thoracic Ultrasound
- What is being tested?
- Diagnostic Thoracic Ultrasound
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People with pleural effusion
Who may be able to join
- Monolateral or Bilateral Pleural Effusion (any cause)
- Able to achieve a sitting position
- Chest CT scan within 24 hours available
- Informed consent available
Who cannot join
- No informed consent available
- Age under 18
- No recent Chest CT scan available
- Unable to keep the sitting position
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is the feasibility assessment of a simple and affordable model for the quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the effusion in correspondence of the midline of hPEUS (aPEUS). The proposed model will estimate the Pleural effusion volume (PEVUS) by multiplying hPEUS and aPEUS. PEVUS will be compared with volumes estimated by CT scans (PEVCT), obtained within 24h from the US examination.
Read the detailed description
The pleural fluid is the thin film of serous fluid between the visceral and parietal pleurae, whose physiological value is around 20 mL in healthy adults. It plays crucial role in the respiratory mechanics, as allows the pleurae to slide effortlessly against each other during ventilation, and its surface tension leads to close apposition of the lung surfaces with the chest wall. The abnormal collection of fluid in the pleural cavity is defined pleural effusion (PE). The most common causes of PE in adults are congestive heart failure, liver cirrhosis, pneumonia, malignant pleural disease, pulmonary embolism, and gastrointestinal disease. PE represents the 10% of admissions in pulmonary units, and affects about 10 million people each year in industrialized countries. The high incidence demands methods for PE accurate estimation, in order to guide the clinician in the choice of the adequate therapy and its follow up .
Strategies for the estimation of PE can be divided into: i) qualitative methods, which are non-invasive; and ii) quantitative methods, which are invasive. Qualitative methods provide coarse estimation of PE (minimal, small, moderate and massive PE), and usually ultrasonography (US) is devoted for this aim; quantitative approaches give accurate information about PE volume, at the expenses of the invasiveness, because of the need of X-ray, CT imaging and thoracentesis.
The interest in the use of US for the evaluation of chest diseases, especially for the study of bedridden, critically ill patients increased. In fact, US-based methods present various advantages: i) absence of ionizing radiation; ii) noninvasiveness; iii) they can be performed at the bedside; iv) being inexpensive, can be repeated if necessary; v) short examination time when compared with CT-based methods. Moreover, US methods are particularly sensitive in imaging the chest wall, pleura, and pleural space thanks to their superficial locations, and are often used to detect PE and guide thoracentesis and drainage, especially in minimal effusions.
Some authors proposed approaches for the estimation of PE volume by means of US images. The PE is identified like an anechoic area on the US image. The basic idea is to measure characteristic lengths or surfaces, and to correlate them to the volume. Such approaches can be distinguished into linear and planar. In the linear ones, usually one length (e.g., the high of the PE column, or intrapleural distance) measured on US image is correlated to the PE volume. These methods are assessed by comparing their output with the values obtained by the gold standard (CT, or thoracentesis). The pro of these techniques related to the quick evaluation is restrained by the low accuracy of the estimation.
In the planar approaches, volumes are directly calculated by multiplying a specific length (e.g., the height of the PE column) with the effusion areas measured in correspondence of defined anatomical landmarks (e.g., the half height of PE column). For instance, the model proposed by Remérand et al. requires three measurements: 2 for the detection of the PE column extremities, and 1 for the area. The US exam is performed on supine patients, at the end-expiration. Such approach is more time-consuming than the linear one, but allows achieving more accurate results.
The present study implements a simple and affordable planar model, based on the product between the height of the PE column and the area of the surface at half PE column. Such landmarks can be easily detected by the clinician during the exam. The model requires only two US measurements, performed on seated patients. Volumes estimated by US images are compared with volumes calculated from the CT scans of the patient (gold standard), acquired within the 24 hours.
Materials and Methods:
Images collection In this retrospective study, US images and CT scans will be collected from patients, hospitalized at the Campus Bio Medico Teaching Hospital in Rome. Thoracic and total body CT scans will be performed for clinical reasons related to patients care. The consent to participate a clinical study will be obtained. The CT scans will be collected within 24 hours from the US exam, in order to avoid significant differences due to spontaneous resorption of PE.
Model development Bedside pleural US imaging will be performed using ECM-EXAGYNE with an abdominal convex 3.5 MHz probe. US exam will be performed with the seating patients and the US measurements will be collected at the end-expiration apnea.
The pleural cavity will be explored on frontal plane to detect the maximal height of PE column (hPEUS). In correspondence of the midline of hPEUS, the probe will be rotated of 90° on transverse plane, and the PE area (aPEUS) will be detected. hPEUS and aPEUS will be manually collected.
Thoracic CT scan CT scan will be performed using Somatom Sensation 64 (Siemens) with tube voltage of 120 kVp, tube current of 460mA and B30f as convolution kernel.
The 3.0 mm-thick contiguous sections of the whole lung will be acquired during a prolonged expiratory pause. CT data will be stored on computerized disks and subsequently analyzed using OsiriX software (v7.0.2).
PE volume will be quantified through a manual delineation of cross-sectional PE area. PEVCT will be computed by the software with the sum of the total number of pixels present in all PE cross-sectional area delineated.
The following analysis will be performed:
- Assessment of the intra-observer reproducibility on PEVCT
- Correlation between PE volumes estimated with US and CT
- Conditions
- Pleural Effusion Disorder, Thoracic Ultrasound
- Being tested
- Diagnostic Thoracic Ultrasound
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Thoracic UltrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Study Group with Pleural effusion for any cause and receiving chest CT scan and thoracic Ultrasounds. Receives: Other: Diagnostic Thoracic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of pleural effusion amount by ultrasound in the sitting patient
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scarlata, Simone, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Scarlata, M.D., Principal investigator, Campus Bio Medico University and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809872
- Sponsor's protocol ID
- ScarlataS
- Status last verified
- Jan 2017
- First submitted
- 20 Jun 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Charalampidis C, Youroukou A, Lazaridis G, Baka S, Mpoukovinas I, Karavasilis V, Kioumis I, Pitsiou G, Papaiwannou A, Karavergou A, Tsakiridis K, Katsikogiannis N, Sarika E, Kapanidis K, Sakkas L, Korantzis I, Lampaki S, Zarogoulidis K, Zarogoulidis P. Physiology of the pleural space. J Thorac Dis. 2015 Feb;7(Suppl 1):S33-7. doi: 10.3978/j.issn.2072-1439.2014.12.48.
PubMed 25774305Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
PubMed 26350935Eibenberger KL, Dock WI, Ammann ME, Dorffner R, Hormann MF, Grabenwoger F. Quantification of pleural effusions: sonography versus radiography. Radiology. 1994 Jun;191(3):681-4. doi: 10.1148/radiology.191.3.8184046.
PubMed 8184046Usta E, Mustafi M, Ziemer G. Ultrasound estimation of volume of postoperative pleural effusion in cardiac surgery patients. Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):204-7. doi: 10.1510/icvts.2009.222273. Epub 2009 Nov 10.
PubMed 19903687Remerand F, Dellamonica J, Mao Z, Ferrari F, Bouhemad B, Jianxin Y, Arbelot C, Lu Q, Ichai C, Rouby JJ. Multiplane ultrasound approach to quantify pleural effusion at the bedside. Intensive Care Med. 2010 Apr;36(4):656-64. doi: 10.1007/s00134-010-1769-9. Epub 2010 Feb 6.
PubMed 20140421
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Estimation of Pleural Effusion in the Sitting Patients
- ClinicalTrials.gov ID
- NCT02809872
- Acronym / sponsor ID
- ScarlataS
- Conditions
- Pleural Effusion Disorder, Thoracic Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Scarlata, Simone, M.D.University, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- 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.
The aim of this study is the feasibility assessment of a simple and affordable model for the quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the effusion in correspondence of the midline of hPEUS (aPEUS). The proposed model will estimate the Pleural effusion volume (PEVUS) by multiplying hPEUS and aPEUS. PEVUS will be compared with volumes estimated by CT scans (PEVCT), obtained within 24h from the US examination.
Detailed description
The pleural fluid is the thin film of serous fluid between the visceral and parietal pleurae, whose physiological value is around 20 mL in healthy adults. It plays crucial role in the respiratory mechanics, as allows the pleurae to slide effortlessly against each other during ventilation, and its surface tension leads to close apposition of the lung surfaces with the chest wall. The abnormal collection of fluid in the pleural cavity is defined pleural effusion (PE). The most common causes of PE in adults are congestive heart failure, liver cirrhosis, pneumonia, malignant pleural disease, pulmonary embolism, and gastrointestinal disease. PE represents the 10% of admissions in pulmonary units, and affects about 10 million people each year in industrialized countries. The high incidence demands methods for PE accurate estimation, in order to guide the clinician in the choice of the adequate therapy and its follow up .
Strategies for the estimation of PE can be divided into: i) qualitative methods, which are non-invasive; and ii) quantitative methods, which are invasive. Qualitative methods provide coarse estimation of PE (minimal, small, moderate and massive PE), and usually ultrasonography (US) is devoted for this aim; quantitative approaches give accurate information about PE volume, at the expenses of the invasiveness, because of the need of X-ray, CT imaging and thoracentesis.
The interest in the use of US for the evaluation of chest diseases, especially for the study of bedridden, critically ill patients increased. In fact, US-based methods present various advantages: i) absence of ionizing radiation; ii) noninvasiveness; iii) they can be performed at the bedside; iv) being inexpensive, can be repeated if necessary; v) short examination time when compared with CT-based methods. Moreover, US methods are particularly sensitive in imaging the chest wall, pleura, and pleural space thanks to their superficial locations, and are often used to detect PE and guide thoracentesis and drainage, especially in minimal effusions.
Some authors proposed approaches for the estimation of PE volume by means of US images. The PE is identified like an anechoic area on the US image. The basic idea is to measure characteristic lengths or surfaces, and to correlate them to the volume. Such approaches can be distinguished into linear and planar. In the linear ones, usually one length (e.g., the high of the PE column, or intrapleural distance) measured on US image is correlated to the PE volume. These methods are assessed by comparing their output with the values obtained by the gold standard (CT, or thoracentesis). The pro of these techniques related to the quick evaluation is restrained by the low accuracy of the estimation.
In the planar approaches, volumes are directly calculated by multiplying a specific length (e.g., the height of the PE column) with the effusion areas measured in correspondence of defined anatomical landmarks (e.g., the half height of PE column). For instance, the model proposed by Remérand et al. requires three measurements: 2 for the detection of the PE column extremities, and 1 for the area. The US exam is performed on supine patients, at the end-expiration. Such approach is more time-consuming than the linear one, but allows achieving more accurate results.
The present study implements a simple and affordable planar model, based on the product between the height of the PE column and the area of the surface at half PE column. Such landmarks can be easily detected by the clinician during the exam. The model requires only two US measurements, performed on seated patients. Volumes estimated by US images are compared with volumes calculated from the CT scans of the patient (gold standard), acquired within the 24 hours.
Materials and Methods:
Images collection In this retrospective study, US images and CT scans will be collected from patients, hospitalized at the Campus Bio Medico Teaching Hospital in Rome. Thoracic and total body CT scans will be performed for clinical reasons related to patients care. The consent to participate a clinical study will be obtained. The CT scans will be collected within 24 hours from the US exam, in order to avoid significant differences due to spontaneous resorption of PE.
Model development Bedside pleural US imaging will be performed using ECM-EXAGYNE with an abdominal convex 3.5 MHz probe. US exam will be performed with the seating patients and the US measurements will be collected at the end-expiration apnea.
The pleural cavity will be explored on frontal plane to detect the maximal height of PE column (hPEUS). In correspondence of the midline of hPEUS, the probe will be rotated of 90° on transverse plane, and the PE area (aPEUS) will be detected. hPEUS and aPEUS will be manually collected.
Thoracic CT scan CT scan will be performed using Somatom Sensation 64 (Siemens) with tube voltage of 120 kVp, tube current of 460mA and B30f as convolution kernel.
The 3.0 mm-thick contiguous sections of the whole lung will be acquired during a prolonged expiratory pause. CT data will be stored on computerized disks and subsequently analyzed using OsiriX software (v7.0.2).
PE volume will be quantified through a manual delineation of cross-sectional PE area. PEVCT will be computed by the software with the sum of the total number of pixels present in all PE cross-sectional area delineated.
The following analysis will be performed:
- Assessment of the intra-observer reproducibility on PEVCT
- Correlation between PE volumes estimated with US and CT
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Diagnostic Thoracic UltrasoundStudy Group with Pleural effusion for any cause and receiving chest CT scan and thoracic Ultrasounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with pleural effusion
Key inclusion criteria (4 listed)
- Monolateral or Bilateral Pleural Effusion (any cause)
- Able to achieve a sitting position
- Chest CT scan within 24 hours available
- Informed consent available
Key exclusion criteria (4 listed)
- No informed consent available
- Age under 18
- No recent Chest CT scan available
- Unable to keep the sitting position
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 |
|---|---|---|
| Diagnostic Thoracic Ultrasound | Other | Study Group |
Primary outcome
Estimation of pleural effusion amount by ultrasound in the sitting patient
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Results publication: PubMed 25774305Charalampidis C, Youroukou A, Lazaridis G, Baka S, Mpoukovinas I, Karavasilis V, Kioumis I, Pitsiou G, Papaiwannou A, Karavergou A, Tsakiridis K, Katsikogiannis N, Sarika E, Kapanidis K, Sakkas L, Korantzis I, Lampaki S, Zarogoulidis K, Zarogoulidis P. Physiology of the pleural space. J Thorac Dis. 2015 Feb;7(Suppl 1):S33-7. doi: 10.3978/j.issn.2072-1439.2014.12.48.
- Results publication: PubMed 26350935Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
- Results publication: PubMed 8184046Eibenberger KL, Dock WI, Ammann ME, Dorffner R, Hormann MF, Grabenwoger F. Quantification of pleural effusions: sonography versus radiography. Radiology. 1994 Jun;191(3):681-4. doi: 10.1148/radiology.191.3.8184046.
- Results publication: PubMed 19903687Usta E, Mustafi M, Ziemer G. Ultrasound estimation of volume of postoperative pleural effusion in cardiac surgery patients. Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):204-7. doi: 10.1510/icvts.2009.222273. Epub 2009 Nov 10.
- Results publication: PubMed 20140421Remerand F, Dellamonica J, Mao Z, Ferrari F, Bouhemad B, Jianxin Y, Arbelot C, Lu Q, Ichai C, Rouby JJ. Multiplane ultrasound approach to quantify pleural effusion at the bedside. Intensive Care Med. 2010 Apr;36(4):656-64. doi: 10.1007/s00134-010-1769-9. Epub 2010 Feb 6.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Simone Scarlata, M.D. principal investigator
Campus Bio Medico University and Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion Disorder and Thoracic Ultrasound, run by Scarlata, Simone, M.D. at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. 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 Italy. 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?
Results are not available in the source record.
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?
Estimation of pleural effusion amount by ultrasound in the sitting patient (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809872, which also lists 5 linked publications.
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 31 Jan 2017.