NCT01601444

Brief Summary

Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical detection of pleural effusion is often not possible. Radiographic examination, widely used for detecting pleural effusion ,is not suitable for prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at home The currently available methods for monitoring and early detection such as the measurement of pulmonary capillary wedge pressure or measurement by double indicator thermodilution, are not reliable enough and may themselves lead to complications. Measuring internal thoracic impedance (ITI), the main component of which is lung impedance, is a noninvasive and safe method. PLE will be diagnosed in accordance with well-accepted clinical signs(dyspnea, cyanosis, pulmonary rales, crepitations, arterial hypoxemia) and roentgenological criteria

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

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

First Submitted

Initial submission to the registry

April 30, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

April 30, 2012

Last Update Submit

May 16, 2012

Conditions

Pleural Effusion

Keywords

To assess pleural effusion by measuring internal thoracic impedance

Outcome Measures

Primary Outcomes (1)

  • Internal thoracic impedance

    12 months

Interventions

PletysmographDEVICE

Pletysmograph electrodes are applied to the thoracic wall

Also known as: Edema Guard Monitor (EMG) model RS-207 (RS Medical Monitoring Ltd. Jerusalem, Israel

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary heart disease-(CHD)
  • valvular heart disease
  • renal failure
  • infectious disease malignant diseases( all complicated by pleural effusion).
  • The control group will be comprised of patients 40-90years old without pleural effusion established by chest X-ray.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Charach G, Rubalsky O, Charach L, Rabinovich A, Argov O, Rogowski O, George J. Internal thoracic impedance - a useful method for expedient detection and convenient monitoring of pleural effusion. PLoS One. 2015 Apr 28;10(4):e0122576. doi: 10.1371/journal.pone.0122576. eCollection 2014.

    PMID: 25919389DERIVED

MeSH Terms

Conditions

Pleural Effusion

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Research and Development

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 18, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

May 18, 2012

Record last verified: 2012-05