Monitoring COVID-19 Patients' Lung Fluid Using Impedance Technique

NCT04406493 | Unknown

• 1 other identifier: 0059-20-HYMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ARDS; COVID

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

COVID 19 patients

EXPERIMENTAL

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

Interventions

Lung impedance technique DIAGNOSTIC_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.

COVID 19 patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Covid-19 patient admitted to the infectious unit

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe MC,

Hadera, Israel

RECRUITING

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

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 28, 2020
• Study Start: April 28, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

IL (1)