Monitoring COVID-19 Patients' Lung Fluid Using Impedance Technique

May 27, 2020 updated by: Hillel Yaffe Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Covid-19 patient admitted to the infectious unit

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COVID 19 patients

COVID 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.
Diagnostic test: Lung impedance technique

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
Estimated a month, but could be prolonged through the study completion (one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0059-20-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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