Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
Primary Purpose
Ventilator Associated Pneumonia, Lung Ultrasound
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transthoracic ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator Associated Pneumonia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
lung ultrasound
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
icu stay
Duration of stay in ICU.
hospital stay
Duration of hospital stay.
mortality
mortality from vap
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04057625
Brief Title
Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
Official Title
Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Lung Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lung ultrasound
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transthoracic ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
detecting ultrasound efficiency in diagnosis and follow up of vap
Description
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
icu stay
Description
Duration of stay in ICU.
Time Frame
baseline
Title
hospital stay
Description
Duration of hospital stay.
Time Frame
basline
Title
mortality
Description
mortality from vap
Time Frame
basline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
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