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ARDSNCT04406493

Monitoring COVID-19 Patients' Lung Fluid Using Impedance Technique

A study testing Lung impedance technique in people with ARDS and COVID, run by Hillel Yaffe Medical Center at 1 site in Israel.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the lungs and cause water accumulation in lungs alveolus (ARDS). Today, a chest X-ray is the only practical way to check the degree of lung accumulation. However, X-Ray has many limitations and disadvantages. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
ARDS, COVID
What is being tested?
Lung impedance technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
28 Apr 2020to 28 Apr 2021
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 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Covid-19 patient admitted to the infectious unit

Who cannot join

  • patients who do not agree to sign informed consent, or participating in other studies.

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Hillel Yaffe MC,

    Hadera

    Michael Cleiner, M.D., 972-50-6246926, shochat@hy.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: Monitoring of Lung Fluid Status of Hospitalized COVID-19 Patients by Lung Impedance Technique

COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the lungs and cause water accumulation in lungs alveolus (ARDS).

Today, a chest X-ray is the only practical way to check the degree of lung accumulation. However, X-Ray has many limitations and disadvantages.

Lung impedance technology allows simple lung fluid monitoring, and found to be effective in HF patients who suffer from a similar problem.

The study's aim is to establish a correlation between lung fluid assessed by impedance technique and x-ray examinations. To find a correlation between lung fluid assessment by impedance and clinical parameters of COVID 19 patients.

Read the detailed description

COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the lungs and cause water accumulation in lungs alveolus (ARDS). Water accumulation in pulmonary alveoli leads to fast deterioration and, eventually death. It is important to note that at an early stage of the disease, when the patient feels relatively good, fluid progressively accumulates into the lung.

Today chest X-ray is the only practical way to check the degree of lung accumulation. Chest X ray is a cumbersome method and has a rotational burden. One of the disadvantages of the x-ray is that interpretation of x-ray results are operator dependent. Another disadvantage is the daily monitoring of lung fluids, which is expensive.

Lung impedance technology allows simple lung fluid monitoring, and found to be effective in HF patients who suffers from the same problem, fluid accumulation in lungs. Lung fluid monitoring using lung impedance device may assist physicians to reveal fluid accumulation in lungs, and give better understanding of the severity of the situation. Moreover, better impedance values indicate improvement in patient's condition and also effectiveness of the treatment.

The aim of the study is to prove the correlation between lung fluid assessed by impedance technique and x-ray examinations. To find correlation between lung fluid assessment by impedance and clinical parameters of COVID 19 patients.

In a case that this correlation would be found high, then it will be possible to establish monitoring of lung fluid status of COVID 19 patients using lung impedance device, as a simple and reliable way to determine degree of patient's deterioration as it was proved for HF patients.

The main question, is if a changes in lung fluid status assessed by impedance technique may indicate the need in artificial respiration before there is a drastic Deterioration in patient's condition.

COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using lung impedance device. The first value that has been measured will be set as BASAL.

During hospitalization, each patient will undergo this examination twice a day until discharged.

Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor that predicts mechanical ventilation.

The time between lung impedance started to decrease (expression of the lung fluids accumulation), and the need in mechanical ventilation will be measured.

In a case that lung impedance would be found as a useful predictor of clinical condition in COVID 19 patients, the application for second stage of the study will be submitted to Helsinki Committee.

On the second stage of the study is planning to use lung impedance values as guide for the decision about beginning mechanical ventilation of COVID 19 patients before critical deterioration.

Each patient which is hospitalized in Infectious Diseases Unit of Hillel Yaffe Medical Center suitable for study.

Conditions
ARDS, COVID
Being tested
Lung impedance technique

What participants receive

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

  • Lung impedance techniqueDiagnostic test

    COVID 19 patients are admitted to the Infectious Diseases Unit; they will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.

    During the hospitalization, each patient will undergo this examination twice a day until discharge.

    Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation.

    The time between lung impedance started to decrease (expression of the lung fluids accumulation), and the need for mechanical ventilation will be measured.

Study groups in NCT04406493
Study groupRoleWhat they receive
COVID 19 patientsExperimentalCOVID 19 patients are admitted to the Infectious Diseases Unit, will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL. During the hospitalization each patient will undergo this examination twice a day until discharged. Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need for mechanical ventilation will be measured.
Receives: Diagnostic Test: Lung impedance technique

What is being measured

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

  1. Correlation between impudence deterioration to clinical conditions and hospitalization period

    the changes in lung fluid status assessed by impedance technique will be compared to the patient's clinical conditions and the patient's length of stay.

    Measured: Estimated a month, but could be prolonged through the study completion (one year)

Timeline

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

  1. First posted28 May 2020
  2. Study start28 Apr 2020
  3. Primary completion28 Apr 2021 (estimated)
  4. Study completion28 Apr 2021 (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
Model description
COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using lung impedance device. The first value that has been measured will be set as BASAL. During the hospitalization each patient will undergo this examination twice a day until discharged. Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need in mechanical ventilation will be measured.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406493
Sponsor's protocol ID
0059-20-HYMC
Status last verified
May 2020
First submitted
23 May 2020
Last updated
28 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Lung impedance technique in people with ARDS and COVID, run by Hillel Yaffe Medical Center at 1 site in Israel.

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 1 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 28 May 2020. 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 Israel. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between impudence deterioration to clinical conditions and hospitalization period (time frame: Estimated a month, but could be prolonged through the study completion (one year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 May 2020.

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