Back to resultsThe Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia. (CSS-VAP)
Primary Purpose
Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Closed suction systems
Conventional suction system
Sponsored by
About this trial
This is an interventional prevention trial for Severe Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- invasive mechanical ventilation beyond 48 hours
Exclusion Criteria:
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
Sites / Locations
- State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Closed suction systems
Open (conventional) suction
Arm Description
control group
Outcomes
Primary Outcome Measures
incidence of the ventilator - associated pneumoniae (VAP)
Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed
Contamination of closet inanimate surfaces
Microbiology researching samples from circuit of a respirator and a bed
Secondary Outcome Measures
Organ dysfunction
Patient examination with Sequential Organ Function Assessment (SOFA)
Mortality
Mortality for 28 days of a hospitalization
C - reactive protein
Investigation of a Biomarker of the VAP
Procalcitonin
Investigation of a Biomarker of the VAP
sTREM 1
Investigation of a Biomarker of the VAP
Full Information
NCT ID
NCT04323150
First Posted
March 21, 2020
Last Updated
April 7, 2022
Sponsor
Northern State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04323150
Brief Title
The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
Acronym
CSS-VAP
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury, Pancreatic Diseases, Trauma Injury, Seizures, Encephalitis, Abdominal Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Closed suction systems
Arm Type
Experimental
Arm Title
Open (conventional) suction
Arm Type
Other
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
Closed suction systems
Intervention Description
Closed suction systems are using for prevention of the ventilator-associated pneumoniae
Intervention Type
Device
Intervention Name(s)
Conventional suction system
Intervention Description
The using of open (conventional) suctioning
Primary Outcome Measure Information:
Title
incidence of the ventilator - associated pneumoniae (VAP)
Description
Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed
Time Frame
Change from Baseline CPIS at 96 hours
Title
Contamination of closet inanimate surfaces
Description
Microbiology researching samples from circuit of a respirator and a bed
Time Frame
Change from Baseline Microbiology researching at 96 hours
Secondary Outcome Measure Information:
Title
Organ dysfunction
Description
Patient examination with Sequential Organ Function Assessment (SOFA)
Time Frame
Change from Baseline SOFA at 96 hours
Title
Mortality
Description
Mortality for 28 days of a hospitalization
Time Frame
28 days
Title
C - reactive protein
Description
Investigation of a Biomarker of the VAP
Time Frame
Change from Baseline CRP researching at 96 hours
Title
Procalcitonin
Description
Investigation of a Biomarker of the VAP
Time Frame
Change from Baseline CRP researching at 96 hours
Title
sTREM 1
Description
Investigation of a Biomarker of the VAP
Time Frame
Change from Baseline CRP researching at 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
invasive mechanical ventilation beyond 48 hours
Exclusion Criteria:
hospital - acquired pneumonia
community - acquired pneumoniae
BMI > 35 kg/cm2
pregnancy
tracheostomy
Facility Information:
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
City
Severodvinsk
ZIP/Postal Code
164522
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
Learn more about this trial
The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
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