NCT02809872

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

June 20, 2016

Last Update Submit

January 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Estimation of pleural effusion amount by ultrasound in the sitting patient

    one year

Study Arms (1)

Study Group

Study Group with Pleural effusion for any cause and receiving chest CT scan and thoracic Ultrasounds.

Other: Diagnostic Thoracic Ultrasound

Interventions

Eligibility Criteria

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

People with pleural effusion

You may qualify if:

  • Monolateral or Bilateral Pleural Effusion (any cause)
  • Able to achieve a sitting position
  • Chest CT scan within 24 hours available
  • Informed consent available

You may not qualify if:

  • No informed consent available
  • Age under 18
  • No recent Chest CT scan available
  • Unable to keep the sitting position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio Medico University and Teaching Hospital

Rome, 00128, Italy

Location

Related Publications (5)

  • 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.

  • Bhatnagar 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.

  • Eibenberger 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.

  • Usta 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.

  • Remerand 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.

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Simone Scarlata, M.D.

    Campus Bio Medico University and Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations