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

Not Applicable

Completed

• Conditions: Trauma Injury; Encephalitis; Severe Traumatic Brain Injury; Pancreatic Diseases; Abdominal Sepsis; Seizures
• Interventions: Device: Closed suction systems; Device: Conventional suction system

• Registration Number: NCT04323150
• Lead Sponsor: Northern State Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria

• hospital - acquired pneumonia
• community - acquired pneumoniae
• BMI > 35 kg/cm2
• pregnancy
• tracheostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed suction systems	Closed suction systems	-
Open (conventional) suction	Conventional suction system	control group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Organ dysfunction	Change from Baseline SOFA at 96 hours	Patient examination with Sequential Organ Function Assessment (SOFA)
sTREM 1	Change from Baseline CRP researching at 96 hours	Investigation of a Biomarker of the VAP
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

Trial Locations

Locations (1)

State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"; 🇷🇺 Severodvinsk, Russian Federation