Diagnostic Modalities for VAP Detection

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Diagnostic test: bronchoalveolar lavage

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAP group; patients confirmed diagnosis of VAP with bronchoalveolar lavage	Diagnostic test: bronchoalveolar lavage; endobronchial sampling through bronchoscopy; Other Names: protected endotracheal aspirate
Experimental: Non VAP group; patients confirmed not VAP with bronchoalveolar lavage	Diagnostic test: bronchoalveolar lavage; endobronchial sampling through bronchoscopy; Other Names: protected endotracheal aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To detected diagnostic accuracy of chest ultrasound in VAP.	To identify sensitivity and specificity of chest ultrasound in VAP diagnosis	3 years
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.	To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis	3 years
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.	To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis	3 years
To detected diagnostic accuracy of chest X-ray in VAP.	To identify sensitivity and specificity of chest X-ray in VAP diagnosis	3 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: VAP diagnosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No