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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Severe Traumatic Brain Injury Pancreatic Diseases Trauma Injury Seizures Encephalitis Abdominal Sepsis Device: Closed suction systems Device: Conventional suction system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Closed suction systems Device: Closed suction systems
Closed suction systems are using for prevention of the ventilator-associated pneumoniae

Open (conventional) suction
control group
Device: Conventional suction system
The using of open (conventional) suctioning




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Organ dysfunction [ Time Frame: Change from Baseline SOFA at 96 hours ]
    Patient examination with Sequential Organ Function Assessment (SOFA)

  2. Mortality [ Time Frame: 28 days ]
    Mortality for 28 days of a hospitalization

  3. C - reactive protein [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP

  4. Procalcitonin [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP

  5. sTREM 1 [ Time Frame: Change from Baseline CRP researching at 96 hours ]
    Investigation of a Biomarker of the VAP



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323150


Contacts
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Contact: Konstantin Lapin 960- 006 -15 -87 ext +7 Lapin18151@gmail.com
Contact: Vsevolod Kuzkov, PhD, MD v_kuzkov@mail.ru

Locations
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Russian Federation
State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2" Recruiting
Severodvinsk, Russian Federation, 164522
Contact: Konstantin Lapin    960 - 006 -15-87 ext +7    Lapin18151@gmail.com   
Sponsors and Collaborators
Northern State Medical University
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Responsible Party: Vsevolod V. Kuzkov, Professor of the Department of Anaesthesiology and Intensive Care Medicine, MD, PhD, Northern State Medical University
ClinicalTrials.gov Identifier: NCT04323150    
Other Study ID Numbers: CSS-VAP-1
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pancreatic Diseases
Pneumonia
Brain Injuries
Brain Injuries, Traumatic
Seizures
Encephalitis
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms
Cross Infection
Infection
Digestive System Diseases