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

VAP - Ventilator Associated Pneumonia Clinical Trial

— VAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038814
• Other study ID #: AFMKrakowU
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: Andrzej Frycz Modrzewski Krakow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: July 15, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• VAP - Ventilator Associated Pneumonia

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Anaesthesiology and Intensive Care Unit St. Raphael Hospital	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Andrzej Frycz Modrzewski Krakow University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	LOS	lenght of stay in the ICU (days)	day: 1 - the last day in the ICU, but at least 2 days
Secondary	MV	Duration of mechanical ventilation (days) in the ICU	day: 1 - the last day in the ICU, but at least 2 days
Secondary	nonMV	Total non mechanical ventilation days in the ICU	day: 1 - the last day in the ICU,
Secondary	Mortality	Mortality of adult mechanically ventilated patients in the ICU	day: 1 - 28
Secondary	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,