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

Sponsor

Northern State Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04323150

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Traumatic Brain Injury Pancreatic Diseases Trauma Injury Seizures Encephalitis Abdominal Sepsis	Device: Closed suction systems Device: Conventional suction system	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Closed suction systems

Device: Closed suction systems

Closed suction systems are using for prevention of the ventilator-associated pneumoniae

Other: Open (conventional) suction

control group

Device: Conventional suction system

The using of open (conventional) suctioning

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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