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The Use of Lung Ultrasonography in COVID-19 Patients

Primary Purpose

Ultrasonography

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mechanical ventilator settings and position
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ultrasonography focused on measuring lung ultrasonography, intensive care unit, position, COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients have been diagnosed with COVID 19
  • Patients in the intensive care unit over the age of 18

Exclusion Criteria:

  • Patients not diagnosed with COVID 19
  • Patients with cardiac problems
  • Patients with renal problems

Sites / Locations

  • Gazoosmanpasa Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

GRUP Control

GRUP Ultrasonography

Arm Description

The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.

The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.

Outcomes

Primary Outcome Measures

Change in PO2 values
Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.

Secondary Outcome Measures

Change in PCO2 values
Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.

Full Information

First Posted
June 11, 2020
Last Updated
December 21, 2022
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04432051
Brief Title
The Use of Lung Ultrasonography in COVID-19 Patients
Official Title
The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
August 8, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.
Detailed Description
In this study, the COVID-19 patients hospitalized in the intensive care unit due to respiratory failure will be evaluated. Participants will be divided into two groups as patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung ultrasonography (Group Control). While performing lung ultrasonography, each hemithorax will be evaluated using anterior axillary line and posterior axillary line into anterior, lateral and posterior region, and each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with the Lung Ultrasound Score (LUS score). Participants in both groups will be evaluated by comparing arterial blood gas analyzes before examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and ventilation between Group Ultrasonograpy and Group Control will be evaluated?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasonography
Keywords
lung ultrasonography, intensive care unit, position, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients will be divided into two groups, those with and without ultrasound.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GRUP Control
Arm Type
Placebo Comparator
Arm Description
The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.
Arm Title
GRUP Ultrasonography
Arm Type
Active Comparator
Arm Description
The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.
Intervention Type
Behavioral
Intervention Name(s)
mechanical ventilator settings and position
Intervention Description
Mechanical ventilation settings and patient position will be re-evaluated
Primary Outcome Measure Information:
Title
Change in PO2 values
Description
Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Change in PCO2 values
Description
Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have been diagnosed with COVID 19 Patients in the intensive care unit over the age of 18 Exclusion Criteria: Patients not diagnosed with COVID 19 Patients with cardiac problems Patients with renal problems
Facility Information:
Facility Name
Gazoosmanpasa Education and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Use of Lung Ultrasonography in COVID-19 Patients

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