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

NCT ID: NCT04038814

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-07-15

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.

Detailed Description

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Conditions

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VAP - Ventilator Associated Pneumonia

Keywords

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VAP Evac Endotracheal Tube with TaperGuard Cuff MDR - multi drug resistant pathogens SSD - subglottic secretion drainage,

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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VAP1 - historical group

Routine prevention of VAP

Routine prevention of VAP

Intervention Type 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

VAP2 - study group

Modified prevention of VAP

Modified prevention of VAP

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andrzej Frycz Modrzewski Krakow University

OTHER

Sponsor Role lead

Responsible Party

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JAROSLAW PAWLIK

MD, Specialist of anaesthesiology and intensive care, An assistant of The Faculty of Medicine and Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JAROSLAW PAWLIK, MD

Role: PRINCIPAL_INVESTIGATOR

Andrzej Frycz Modrzewski Krakow University

Locations

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Anaesthesiology and Intensive Care Unit St. Raphael Hospital

Krakow, Małopolska, Poland

Site Status

Countries

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Poland

Other Identifiers

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AFMKrakowU

Identifier Type: -

Identifier Source: org_study_id