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

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ClinicalTrials.gov Identifier: NCT04323150
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Vsevolod V. Kuzkov, Northern State Medical University

Tracking Information
First Submitted Date  ICMJE March 21, 2020
First Posted Date  ICMJE March 26, 2020
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • incidence of the ventilator - associated pneumoniae (VAP) [ Time Frame: 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 [ Time Frame: Change from Baseline Microbiology researching at 96 hours ]
    Microbiology researching samples from circuit of a respirator and a bed
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • Organ dysfunction [ Time Frame: Change from Baseline SOFA at 96 hours ]
    Patient examination with Sequential Organ Function Assessment (SOFA)
  • Mortality [ Time Frame: 28 days ]
    Mortality for 28 days of a hospitalization
  • C - reactive protein [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP
  • Procalcitonin [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP
  • sTREM 1 [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
Official Title  ICMJE The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Severe Traumatic Brain Injury
  • Pancreatic Diseases
  • Trauma Injury
  • Seizures
  • Encephalitis
  • Abdominal Sepsis
Intervention  ICMJE
  • Device: Closed suction systems
    Closed suction systems are using for prevention of the ventilator-associated pneumoniae
  • Device: Conventional suction system
    The using of open (conventional) suctioning
Study Arms  ICMJE
  • Experimental: Closed suction systems
    Intervention: Device: Closed suction systems
  • Open (conventional) suction
    control group
    Intervention: Device: Conventional suction system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

  • hospital - acquired pneumonia
  • community - acquired pneumoniae
  • BMI > 35 kg/cm2
  • pregnancy
  • tracheostomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Konstantin Lapin 960- 006 -15 -87 ext +7 Lapin18151@gmail.com
Contact: Vsevolod Kuzkov, PhD, MD v_kuzkov@mail.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04323150
Other Study ID Numbers  ICMJE CSS-VAP-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Responsible Party Vsevolod V. Kuzkov, Northern State Medical University
Study Sponsor  ICMJE Northern State Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northern State Medical University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP