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Pleural EffusionNCT01601444

Detection of Pleural Effusion by Internal Thoracic Impedance Method

A study testing Pletysmograph in people with Pleural Effusion, run by Michal Roll PhD,MBA.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Pleural Effusion
What is being tested?
Pletysmograph
Type of treatment
Medical device
How many people
100 participants
Where
No sites listed yet
Study dates
Jun 2012to Aug 2013
Phase
Interventional
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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria for study group will be as follows: patients 40-90 year old with pleural effusion on chest X-ray of different etiologies:
  • 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.

Who cannot join

  • The exclusion criteria will be respiratory failure due to diseases, wearing a pacemaker,thoracic deformation, pulmonary edema and embolism

About this study

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

Read the detailed description

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 (1-9).

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(2-8).

Yu C-M et al.(9) recently reported successful prediction of CPE by a surgically implanted impedance plethysmograph integrated into a pacemaker . The system was shown to be sufficiently sensitive for cardiogenic pulmonary edema preceding. However this method is invasive and not suitable for wide use (9).

Therefore, these methods are seldom employed for the detection of PLE (3-7). Thus, a safe and accurate technique for early detection and monitoring of PlEf would be of great clinical value. The changes in the blood and extravascular fluid content in the lungs in humans and animals can be easily monitored using a noninvasive and totally safe procedure based on impedance plethysmography (5-12-). This method is based on the fact that the impedance of the lungs decreases with the increase in the fluid and free ions content in them (8,13,). However, it proved to be unsuitable for preclinical stage monitoring of PLE (2-8) for several reasons, mainly the low sensitivity of the existing impedance plethysmographs. This is due to the high skin-electrode contact resistance (13,14), which is of an order of magnitude high erthan the impedance of the lung.

After cleaning the skin of fats with alcohol and moistening it with electrode paste, the value of the skin electrode contact resistance is approximately 400- 500 ohm (11-13). Therefore, for two measuring electrodes (front and back of the chest), this value must be 800-1000 ohm.

Total transthoracic impedance (TTI) consists of internal thoracic impedance (ITI) and skin contact impedance. The TTI may vary from 920 to 1230 ohm in different individuals (11-13). However, change of TTI in PLE was reported by others to vary in the range of 2-16 ohm (7-9, 11-18), which is approximately1% of TTI and 1.5% of skin contact impedance. Monitors used in previous works were not sensitive enough to detect the relatively small changes in pulmonary impedance(2-7).

In addition, during prolonged monitoring, the skin-electrode contact impedance may also change (13,14) due to penetration of the ions from sweat into the electrode paste and drying of the paste. It may significantly exceed the change in the impedance of the lung caused by the development of cardiogenic pulmonary edema (2-7). Kubicek et al. (10) attempted to develop a method in which a tetrapolar electrode system is used to overcome this problem.

However, because this system measures the impedance of the entire chest, a large part of the electrical field is concentrated in the surface tissues, and this considerably reduces the sensitivity of the method (10,11). Furthermore, Kubicek's electrodes may be burdensome and for critically ill patients when prolonged monitoring is required. The main disadvantage of this and other more sensitive methods is surgical implantation of the electrodes (10,13) A new impedance monitor, model RS- 207 EDEMA GUARD MONITOR (R. S. Medical Monitoring, Jerusalem, Israel), has been developed (15). The monitor design has also solved the problem of the drift skin-to-electrode electrical resistance and its drift during prolonged monitoring by separating ITI from skin-to-electrode electrical resistance. The result of the above mentioned actions is a value of Internal Thoracic Electrical Resistance (Impedance) - ITI. The method of ITI estimation that completely described by Rabinovich (15) Unlike the existing impedance monitors, the new monitor measures only ITI, which roughly equals lung impedance, by automatically calculating skin electrode impedance and subtracting it from TTI. According to the published data, ITI ranges from 40 to 100 ohm in individuals without CPE and, on average, decreases to 30 ohm, i.e., by30% to 75% during CPE (11-12,16-21). These results showed much higher sensitivity compared with the 1.5% changes found using TTI methods. This is an average 35- fold increase (range, 20- to 50-fold intraindividual constitutional differences) of impedance plethysmograph sensitivity compared with the method without substraction of skin electrode resistance (2-8). This monitor was succefully used for early detection of pulmonary edema however there was no any expearence on pleural fluid detection.(11,12,16-20.) The aim of the present study is to evaluate the suitability of the RS-207 in monitoring PlEf at clinical and preclinical stage. The tests will be considered successful if ITI will be low or decreased parallel to or before the appearance of clinical signs and radiograph findings compatible with PlEf, and then demonstrably increased during their resolution.

Considerations and purpose Previous study based on measurements of ITI in early diagnosis of pulmonary edema showed suitability of the RS-207.

There is no any study that deals with early diagnosis of pleural effusion by this simple nonexpencive method which can be used in ICU and ambulatory Measuring 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.

The consideration of the study : evaluation of the suitability of the RS-205 monitor in detecting the PLE at preclinical stage before the appearance of clinical signs for assessment of early treatment and then to demonstrate increased of ITI during their resolution.

Being tested
Pletysmograph
Keywords
To assess pleural effusion by measuring internal thoracic impedance
Medical subject headings
Pleural Effusion

What participants receive

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

  • PletysmographDevice

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

    Pletysmograph electrodes are applied to the thoracic wall

What is being measured

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

  1. Internal thoracic impedance

    Measured: 12 months

Timeline

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

  1. First posted18 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionMay 2013 (estimated)
  4. Study completionAug 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601444
Sponsor's protocol ID
TASMC-11-CG-504-CTIL
Status last verified
May 2012
First submitted
30 Apr 2012
Last updated
18 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25919389

Questions about this trial

What is this clinical trial studying?

A study testing Pletysmograph in people with Pleural Effusion, run by Michal Roll PhD,MBA.

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 6 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: status not confirmed, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Internal thoracic impedance (time frame: 12 months). 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 NCT01601444, which also lists 1 linked publication.

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 May 2012.

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