VAP - Ventilator Associated PneumoniaVAPNCT04038814
The Effectiveness of the Modified Bundle in the Prevention of VAP.
An observational study of VAP - Ventilator Associated Pneumonia, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- Routine prevention of VAP and Modified prevention of VAP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 386 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2018to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Anaesthesiology and Intensive Care Unit St. Raphael Hospital
Krakow, Małopolska, 30-693
About this study
Official title: 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.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- Routine prevention of VAP, Modified prevention of VAP
- Keywords
- VAP, Evac Endotracheal Tube with TaperGuard Cuff, MDR - multi drug resistant pathogens, SSD - subglottic secretion drainage,
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine prevention of VAPProcedure or surgery
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 VAPProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| VAP1 - historical group | Routine prevention of VAP Receives: Procedure: Routine prevention of VAP | |
| VAP2 - study group | Modified prevention of VAP Receives: Procedure: Modified prevention of VAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early VAP
Total VAP cases in the ICU ( CEPPIS /Chest Echocardiography and Procalcitonin Pulmonary Infection Score/ criteria ) with early beginning of the pneumonia symptoms.
Measured: day: 2 - 5 of mechanical ventilation
Late VAP
total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms
Measured: day: 6 - the last day in ICU
Secondary outcomes (5)
LOS
lenght of stay in the ICU (days)
Measured: day: 1 - the last day in the ICU, but at least 2 days
MV
Duration of mechanical ventilation (days) in the ICU
Measured: day: 1 - the last day in the ICU, but at least 2 days
nonMV
Total non mechanical ventilation days in the ICU
Measured: day: 1 - the last day in the ICU,
Mortality
Mortality of adult mechanically ventilated patients in the ICU
Measured: 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.
Measured: day: 1 - the last day in the ICU,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Jun 2018
- Primary completion1 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAROSLAW PAWLIK, Andrzej Frycz Modrzewski Krakow University
- Investigators
- JAROSLAW PAWLIK, MD, Principal investigator, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038814
- Sponsor's protocol ID
- AFMKrakowU
- Acronym
- VAP
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Modified Bundle in the Prevention of Ventilator-associated Pneumonia in Adult Patients in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT04038814
- Acronym / sponsor ID
- VAP / AFMKrakowU
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- VAP, Evac Endotracheal Tube with TaperGuard Cuff, MDR - multi drug resistant pathogens, SSD - subglottic secretion drainage,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAP1 - historical group | – | Procedure: Routine prevention of VAPRoutine prevention of VAP |
| VAP2 - study group | – | Procedure: Modified prevention of VAPModified prevention of VAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine prevention of VAPEnhanced 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 | Procedure or surgery | VAP1 - historical group |
| Modified prevention of VAP3 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 | Procedure or surgery | VAP2 - study group |
Primary outcome
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.
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
5 secondary outcomes
LOS
Time frame: day: 1 - the last day in the ICU, but at least 2 days
MV
Time frame: day: 1 - the last day in the ICU, but at least 2 days
nonMV
Time frame: day: 1 - the last day in the ICU,
Mortality
Time frame: day: 1 - 28
MDR
Time frame: day: 1 - the last day in the ICU,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JAROSLAW PAWLIK, MD principal investigator
Andrzej Frycz Modrzewski Krakow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VAP - Ventilator Associated Pneumonia, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early VAP (time frame: day: 2 - 5 of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.