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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04323150
Other study ID # CSS-VAP-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date December 31, 2020

Study information

Verified date April 2022
Source Northern State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - invasive mechanical ventilation beyond 48 hours Exclusion Criteria: - hospital - acquired pneumonia - community - acquired pneumoniae - BMI > 35 kg/cm2 - pregnancy - tracheostomy

Study Design


Intervention

Device:
Closed suction systems
Closed suction systems are using for prevention of the ventilator-associated pneumoniae
Conventional suction system
The using of open (conventional) suctioning

Locations

Country Name City State
Russian Federation State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2" Severodvinsk

Sponsors (1)

Lead Sponsor Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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