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

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

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis; Seizures; Pancreatic Diseases; Trauma Injury; Severe Traumatic Brain Injury; Abdominal Sepsis
• Intervention / Treatment: Device: Closed suction systems; Device: Conventional suction system

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Severodvinsk, Russian Federation, 164522
    • State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Northern State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Disease Attributes; Cross Infection; Iatrogenic Disease; Craniocerebral Trauma; Trauma, Nervous System; Healthcare-Associated Pneumonia; Encephalitis; Brain Injuries; Pneumonia; Wounds and Injuries; Intraabdominal Infections; Brain Injuries, Traumatic; Seizures; Pneumonia, Ventilator-Associated; Pancreatic Diseases
• Other Study ID Numbers: CSS-VAP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No