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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04057625
Other study ID # sonar in vap
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date October 2020

Study information

Verified date August 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date October 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary detecting ultrasound efficiency in diagnosis and follow up of vap Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia. baseline
Secondary icu stay Duration of stay in ICU. baseline
Secondary hospital stay Duration of hospital stay. basline
Secondary mortality mortality from vap basline
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