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Diagnostic Modalities for VAP Detection

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bronchoalveolar lavage
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:

  • All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.

who had:

  • Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
  • Or new or extension of a radiological image with at least two of the following clinical criteria:

    • Body temperature ≥ 38.5 ° C or <36 ° C.
    • Leukocytes> 10 * 103 / ml or <4 * 103/ ml or > 10% immature cells (in the absence of other known causes).
    • Purulent tracheal secretions.
    • Hypoxemia with PaO2 <60 mmHg or a PaO2 / FiO2 <300.

Exclusion Criteria:

  • Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
  • Patients who are contraindicated for bronchoscopy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    VAP group

    Non VAP group

    Arm Description

    patients confirmed diagnosis of VAP with bronchoalveolar lavage

    patients confirmed not VAP with bronchoalveolar lavage

    Outcomes

    Primary Outcome Measures

    To detected diagnostic accuracy of chest ultrasound in VAP.
    To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
    To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
    To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
    To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
    To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
    To detected diagnostic accuracy of chest X-ray in VAP.
    To identify sensitivity and specificity of chest X-ray in VAP diagnosis

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2021
    Last Updated
    May 30, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04911244
    Brief Title
    Diagnostic Modalities for VAP Detection
    Official Title
    Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    October 2019 (Actual)
    Study Completion Date
    February 2020 (Actual)

    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
    asses diagnostic performance of different methods for detection of ventilator associated pneumonia.
    Detailed Description
    Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources. The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited. The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial . Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP. Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Allocation
    Non-Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VAP group
    Arm Type
    Experimental
    Arm Description
    patients confirmed diagnosis of VAP with bronchoalveolar lavage
    Arm Title
    Non VAP group
    Arm Type
    Experimental
    Arm Description
    patients confirmed not VAP with bronchoalveolar lavage
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    bronchoalveolar lavage
    Other Intervention Name(s)
    protected endotracheal aspirate
    Intervention Description
    endobronchial sampling through bronchoscopy
    Primary Outcome Measure Information:
    Title
    To detected diagnostic accuracy of chest ultrasound in VAP.
    Description
    To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
    Time Frame
    3 years
    Title
    To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
    Description
    To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
    Time Frame
    3 years
    Title
    To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
    Description
    To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
    Time Frame
    3 years
    Title
    To detected diagnostic accuracy of chest X-ray in VAP.
    Description
    To identify sensitivity and specificity of chest X-ray in VAP diagnosis
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study. who had: Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6. Or new or extension of a radiological image with at least two of the following clinical criteria: Body temperature ≥ 38.5 ° C or <36 ° C. Leukocytes> 10 * 103 / ml or <4 * 103/ ml or > 10% immature cells (in the absence of other known causes). Purulent tracheal secretions. Hypoxemia with PaO2 <60 mmHg or a PaO2 / FiO2 <300. Exclusion Criteria: Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation. Patients who are contraindicated for bronchoscopy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25427866
    Citation
    Nair GB, Niederman MS. Ventilator-associated pneumonia: present understanding and ongoing debates. Intensive Care Med. 2015 Jan;41(1):34-48. doi: 10.1007/s00134-014-3564-5. Epub 2014 Nov 27.
    Results Reference
    background
    PubMed Identifier
    19633538
    Citation
    Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
    Results Reference
    background
    PubMed Identifier
    26836896
    Citation
    Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
    Results Reference
    background

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    Diagnostic Modalities for VAP Detection

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