Diagnostic Modalities for VAP Detection
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bronchoalveolar lavage
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator Associated Pneumonia
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
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
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
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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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