The Effectiveness of the Modified Bundle in the Prevention of VAP.

Study Overview
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Brief Summary
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Ventilator-associated pneumonia (VAP) is an important cause of prolonged intensive care unit and hospital length of stay, healthcare costs and mortality in mechanically ventilated patients. There are an international guidelines for VAP diagnosis, treatment and prevention (Infectious Diseases Society of America(IDSA)/American Thoracic Society (ATS) 2016 and European Respiratory Society (ERS) / European Society of Intensive Care Medicine (ESICM) / European Society of Clinical Microbiology and Infectiuos Diseases (ESCMID) / Asociacion Latinoamericana del Torax (ALAT) 2017) routinely used in most ICUs. The investigator planed on comparing two strategies for prevention of VAP in mechanically ventilated patients: the routine VAP bundle ( historical group - VAP1) and the modified VAP bundle ( study group - VAP2) by using 3 modifications ( Shiley Evac Endotracheal tube with TaperGuard Cuff, Automatic continuous subglottic secretion drainage (SSD) and continuous tube cuff pressure monitoring). The aim of the study is an assessment of the effectiveness of the modified prevention of VAP in reduction of: early and late VAP cases, mechanical ventilation days (MV), length of stay (LOS) in the ICU, 28 day mortality and multi drug resistent pathogens (MDR) cases in adult ICU patients.

Official Title
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The Effectiveness of the Modified Bundle in the Prevention of Ventilator-associated Pneumonia in Adult Patients in the Intensive Care Unit.

Conditions
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VAP - Ventilator Associated Pneumonia

Intervention / Treatment
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* Procedure: Routine prevention of VAP
* Procedure: Modified prevention of VAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VAP2 - study group mechanically ventilated patients with an artificial airways (endotracheal tube, tracheostomy tube) age over 18 years modified bundle in the prevention of VAP VAP1 - historical group mechanically ventilated patients with an artificial airways (endotracheal tube, tracheostomy tube) patients hospitalised in the ICU for last 12 months before modified bundle in the prevention of VAP has been started (from 01.05.2017 to 30.04.2018) age over 18 years routine bundle in the prevention of VAP Exclusion Criteria: lack of an informed consent in awake patients in the ICU age under 18 years patients with no mechanical ventilation in the ICU patients with probability of mechanical ventilation days and LOS in the ICU less than 48 hours patients intubated and mechanically ventilated without the bundle in the prevention of VAP for a period of time longer than 12 hours before the admission to the ICU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VAP1 - historical group<br>Routine prevention of VAP | Procedure: Routine prevention of VAP<br>* Enhanced hand hygiene protocol, tube cuff pressure monitoring ( set on 25-30 mm Hg) every 12 hours and every time when we suspected under or over distention, fast withdrawal of sedation, moderate supportive mechanical ventilation ( tidal volume (VT) 5-8 ml/kg ideal body weight (IBW), positive end expiratory pressure (PEEP) 3-5 cmH2O, Plateau pressure (Ppl) < 25 cm H2O, normocapnia ), Proton Pump Inhibitors (PPIs) reduction, Selective oral decontamination (SOD) every 8 hours - 0,2% chlorhexidine digluconate mouthwash, Closed Tracheal Suction System (CTSS) - changed every 7 day, 30-45% lifting of the thorax<br>|
| VAP2 - study group<br>Modified prevention of VAP | Procedure: Modified prevention of VAP<br>* 3 modifications of the routine bundle in the prevention of VAP: Endotracheal tube ( Shiley Evac Endotracheal tube with TaperGuard Cuff) and tracheostomy tubes (Tracheostomy Tube Cuffed Seal Guard) instead of regular tubes, Automatic, continuous tube cuff pressure monitoring ( Covidien Shiley M Pressure Control Automatic Cuff Controller ( 25-30 mmHg), Automatic continuous subglottic secretion drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early VAP | Total VAP cases in the ICU ( CEPPIS /Chest Echocardiography and Procalcitonin Pulmonary Infection Score/ criteria ) with early beginning of the pneumonia symptoms. | day: 2 - 5 of mechanical ventilation | 
| Late VAP | total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms | day: 6 - the last day in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS | lenght of stay in the ICU (days) | day: 1 - the last day in the ICU, but at least 2 days | 
| MV | Duration of mechanical ventilation (days) in the ICU | day: 1 - the last day in the ICU, but at least 2 days | 
| nonMV | Total non mechanical ventilation days in the ICU | day: 1 - the last day in the ICU, | 
| Mortality | Mortality of adult mechanically ventilated patients in the ICU | day: 1 - 28 | 
| MDR | Number of cases with multi drug resistant (MDR) pathogens detected in specimens of mucus taken from the lower airways in mechanically ventilated patients in the ICU. | day: 1 - the last day in the ICU, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAP, Evac Endotracheal Tube with TaperGuard Cuff, MDR - multi drug resistant pathogens, SSD - subglottic secretion drainage,