Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia

August 22, 2019 updated by: dina reda ragab gharieb, Assiut University
To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

VAP is the most frequent hospital-acquired infection in intensive care units. Depending on the diagnostic criteria used, its incidence ranges from 5% to 67%. The risk of acquiring VAP is 3% per day during the first 5 days on mechanical ventilation, and it is decreased to 1% per day for the following days.

VAP is suspected when subject shows high grade fever, increase in leukocyte count, change in color of sputum and tachypnea. It's a leading cause of mortality in 15- 65% of the cases.

Serial chest x-ray for diagnosis and follow up, done at time of diagnosis, after 5 days and after 10 days. Chest radiography is consistently carried out after LUS , LUS is done every other day, measuring the largest area of consolidation according to the intercostal space and direction of the probe . Chest radiography is read by two physicians.

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mechanical ventilation for at least 48 hours.
  • New or evolving infiltrate on chest radiograph (CXR).
  • Clinical pulmonary infection score more than or equal 6

Exclusion Criteria:

  • Patients who are less than 18 years old.
  • Patients who have evidence of pneumonia before or prior to being mechanically ventilated.
  • Patients with pulmonary infarction.

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
Intervention / Treatment
Other: lung ultrasound
using lung ultrasound in diagnosis and follow up of vap measuring the largest area of consolidation according to intercostal space and the direction of the probe
Device: transthoracic ultrasound
using transthoracic ultrasound in the diagnosis and follow up of vap,measuring the largest area of consolidation according to intercostal space and the direction of the probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detecting ultrasound efficiency in diagnosis and follow up of vap
Time Frame: baseline
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
icu stay
Time Frame: baseline
Duration of stay in ICU.
baseline
hospital stay
Time Frame: basline
Duration of hospital stay.
basline
mortality
Time Frame: basline
mortality from vap
basline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sonar in vap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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