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NCT Number: NCT04038814

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

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.

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Key information

Conditions

VAP - Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anaesthesiology and Intensive Care Unit St. Raphael Hospital

Krakow, Małopolska, 30-693, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine prevention of VAP

Procedure

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

Modified prevention of VAP

Procedure

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

Primary outcomes

  1. Early VAP

    Time frame: day: 2 - 5 of mechanical ventilation

    Total VAP cases in the ICU ( CEPPIS /Chest Echocardiography and Procalcitonin Pulmonary Infection Score/ criteria ) with early beginning of the pneumonia symptoms.

  2. Late VAP

    Time frame: day: 6 - the last day in ICU

    total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms

Secondary outcomes

  1. LOS

    Time frame: day: 1 - the last day in the ICU, but at least 2 days

    lenght of stay in the ICU (days)

  2. MV

    Time frame: day: 1 - the last day in the ICU, but at least 2 days

    Duration of mechanical ventilation (days) in the ICU

  3. nonMV

    Time frame: day: 1 - the last day in the ICU,

    Total non mechanical ventilation days in the ICU

  4. Mortality

    Time frame: day: 1 - 28

    Mortality of adult mechanically ventilated patients in the ICU

  5. MDR

    Time frame: day: 1 - the last day in the ICU,

    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.

Sponsors and collaborators

Lead sponsor

Andrzej Frycz Modrzewski Krakow University

Other

Registry information

Official study title

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

Acronym: VAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2019
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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