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

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

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.

Study Overview

• Status: Completed
• Conditions: VAP - Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Routine prevention of VAP; Procedure: Modified prevention of VAP

• Study Type: Observational
• Enrollment (Actual): 386

Contacts and Locations

Study Locations

• Poland
  • Małopolska
    • Kraków, Małopolska, Poland, 30-693
      • Anaesthesiology and Intensive Care Unit St. Raphael Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group were male and female patients ( neurosurgical, cardiological, general surgical and non cardiological internal medicine type) in adult ICU. Each enrolled patient was mechanically ventilated for a period longer than 48 hours.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VAP1 - historical group; Routine prevention of VAP	Procedure: Routine prevention of VAP; 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
VAP2 - study group; Modified prevention of VAP	Procedure: Modified prevention of VAP; 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

What is the study measuring?

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,

Collaborators and Investigators

• Sponsor: Andrzej Frycz Modrzewski Krakow University
• Investigators: Principal Investigator: JAROSLAW PAWLIK, MD, Andrzej Frycz Modrzewski Krakow University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: VAP; Evac Endotracheal Tube with TaperGuard Cuff; MDR - multi drug resistant pathogens; SSD - subglottic secretion drainage,
• 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
• Other Study ID Numbers: AFMKrakowU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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