search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventilator Associated Pneumonia

Eligibility Criteria

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

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

    First Posted
    August 14, 2019
    Last Updated
    August 22, 2019
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs