Diagnostic Modalities for VAP Detection

Ventilator Associated Pneumonia Clinical Trial

Official title:

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911244
• Other study ID #: VAP diagnosis
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2020

Study information

• Verified date: May 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Diagnostic Test:
• bronchoalveolar lavage
endobronchial sampling through bronchoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detected diagnostic accuracy of chest ultrasound in VAP.	To identify sensitivity and specificity of chest ultrasound in VAP diagnosis	3 years
Primary	To detected diagnostic accuracy of protected endotracheal aspirate in VAP.	To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis	3 years
Primary	To detected diagnostic accuracy of usual endotracheal aspirate in VAP.	To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis	3 years
Primary	To detected diagnostic accuracy of chest X-ray in VAP.	To identify sensitivity and specificity of chest X-ray in VAP diagnosis	3 years