Diagnostic Modalities for VAP Detection

NCT ID: NCT04911244

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-02-29

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC

Study Groups

VAP group

patients confirmed diagnosis of VAP with bronchoalveolar lavage

Group Type: EXPERIMENTAL

bronchoalveolar lavage

Intervention Type: DIAGNOSTIC_TEST

endobronchial sampling through bronchoscopy

Non VAP group

patients confirmed not VAP with bronchoalveolar lavage

Group Type: EXPERIMENTAL

bronchoalveolar lavage

Intervention Type: DIAGNOSTIC_TEST

endobronchial sampling through bronchoscopy

Interventions

bronchoalveolar lavage

endobronchial sampling through bronchoscopy

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

protected endotracheal aspirate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Refaat Mahmoud

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 25427866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19633538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26836896 (View on PubMed)

Other Identifiers

VAP diagnosis

Identifier Type: -

Identifier Source: org_study_id