The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.

Study Overview
=================
Brief Summary
-----------------
The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.

Official Title
-----------------
The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.

Conditions
-----------------
Seizures, Encephalitis, Abdominal Sepsis, Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury

Intervention / Treatment
-----------------
* Device: Closed suction systems
* Device: Conventional suction system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: invasive mechanical ventilation beyond 48 hours Exclusion Criteria: hospital - acquired pneumonia community - acquired pneumoniae BMI > 35 kg/cm2 pregnancy tracheostomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed suction systems<br> | Device: Closed suction systems<br>* Closed suction systems are using for prevention of the ventilator-associated pneumoniae<br>|
| Other: Open (conventional) suction<br>control group | Device: Conventional suction system<br>* The using of open (conventional) suctioning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of the ventilator - associated pneumoniae (VAP) | Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed | Change from Baseline CPIS at 96 hours | 
| Contamination of closet inanimate surfaces | Microbiology researching samples from circuit of a respirator and a bed | Change from Baseline Microbiology researching at 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ dysfunction | Patient examination with Sequential Organ Function Assessment (SOFA) | Change from Baseline SOFA at 96 hours | 
| Mortality | Mortality for 28 days of a hospitalization | 28 days | 
| C - reactive protein | Investigation of a Biomarker of the VAP | Change from Baseline CRP researching at 96 hours | 
| Procalcitonin | Investigation of a Biomarker of the VAP | Change from Baseline CRP researching at 96 hours | 
| sTREM 1 | Investigation of a Biomarker of the VAP | Change from Baseline CRP researching at 96 hours |